21 U.S.C. § 374

Section 374 · Inspection

Current version, with additions and removals from the October 26, 2002 version.

Current — December 29, 2022

As of October 26, 2002

(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions

(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this ~~title~~ when the ~~Secretary has a reasonable belief that an article~~ of ~~food is adulterated and presents a threat~~ of ~~serious adverse health consequences or death to humans or animals,~~ subject to the limitations established in section 350c(d) of this title. In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, or ~~restricted devices~~ are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, or ~~restricted devices~~ which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter. No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data (other than data relating to new drugs, antibiotic drugs, and ~~devices~~ and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) 1 section ~~360i, or~~ 360j(g) of this title, and data relating to other ~~drugs~~ or ~~devices~~ which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 355(j) of this title). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.

(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to the limitations established in section 350c(d) of this title. In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies. In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter. No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data (other than data relating to new drugs, antibiotic drugs, devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 355(j) of this title). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.

(2) The provisions of the third sentence of paragraph (1) shall not apply to—

(A) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail;

(B) practitioners licensed by law to prescribe or administer drugs, or prescribe or use devices, as the case may be, and who manufacture, prepare, propagate, compound, or process drugs, or manufacture or process devices, solely for use in the course of their professional practice;

(C) persons who manufacture, prepare, propagate, compound, or process drugs or manufacture or process devices, solely for use in research, teaching, or chemical analysis and not for sale;

(D) such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that inspection as applied to such classes of persons in accordance with this section is not necessary for the protection of the public health.

(3) An officer or employee making an inspection under paragraph (1) for purposes of enforcing the requirements of section 350a of this title applicable to infant formulas shall be permitted, at all reasonable times, to have access to and to copy and verify any records—

(A) bearing on whether the infant formula manufactured or held in the facility inspected meets the requirements of section 350a of this title, or

(B) required to be maintained under section 350a of this title.

(4)(A) Any records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C), shall, upon the request of the Secretary, be provided to the Secretary by such person, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such person. The Secretary's request shall include a sufficient description of the records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.

(B) Upon receipt of the records requested under subparagraph (A), the Secretary shall provide to the person confirmation of receipt.

(C) The Secretary may rely on any records or other information that the Secretary may inspect under this section to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies identified during such inspections, if applicable and appropriate.

(D) Nothing in this paragraph supplants the authority of the Secretary to conduct inspections otherwise permitted under this chapter in order to ensure compliance with this chapter.

(5)(A) The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], enter sites and facilities specified in subparagraph (C) in order to inspect such records or other information.

(B) An inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph (E), including records and information related to the conduct, results, and analyses of, and the protection of human and animal trial participants participating in, such studies.

(C)(i) The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with—

(I) developing an application or other submission to the Secretary under this chapter or the Public Health Service Act related to marketing authorization for a product described in paragraph (1);

(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or

(III) holding any records or other information described in subparagraph (B).

(ii) A person described in this clause is—

(I) the sponsor of an application or submission specified in subparagraph (E);

(II) a person engaged in any activity described in clause (i) on behalf of such a sponsor, through a contract, grant, or other business arrangement with such sponsor;

(III) an institutional review board, or other individual or entity, engaged by contract, grant, or other business arrangement with a nonsponsor in preparing, collecting, or analyzing records or other information described in subparagraph (B); or

(IV) any person not otherwise described in this clause that conducts, or has conducted, a study described in subparagraph (E) yielding records or other information described in subparagraph (B).

(D)(i) Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including—

(I) permitting the Secretary to record or copy such information for purposes of this paragraph;

(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and

(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred.

(ii) Nothing in clause (i) shall negate, supersede, or otherwise affect the applicability of provisions, under this or any other Act, preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret.

(iii) An inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner.

(E) The studies and submissions described in this subparagraph are each of the following:

(i) Clinical and nonclinical studies submitted to the Secretary in support of, or otherwise related to, applications and other submissions to the Secretary under this chapter or the Public Health Service Act for marketing authorization of a product described in paragraph (1).

(ii) Postmarket safety activities conducted under this chapter or the Public Health Service Act.

(iii) Any other clinical investigation of—

(I) a drug subject to section 355 or 360b of this title or section 262 of title 42; or

(II) a device subject to section 360j(g) of this title.

(iv) Any other submissions made under this chapter or the Public Health Service Act with respect to which the Secretary determines an inspection under this paragraph is warranted in the interest of public health.

(F) This paragraph clarifies the authority of the Secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that, prior to December 29, 2022, the Secretary lacked the authority to conduct such inspections, including under this chapter or the Public Health Service Act.

(b) Written report to owner; copy to Secretary

Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, or cosmetic in such establishment ~~(1)~~ consists in whole or in part of any filthy, putrid, or decomposed substance, or ~~(2)~~ has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary.

(1) Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, tobacco product, or cosmetic in such establishment (A) consists in whole or in part of any filthy, putrid, or decomposed substance, or (B) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary.

(2) In carrying out this subsection with respect to any establishment manufacturing a drug approved under subsection (c) or (j) of section 355 of this title for which a notification has been submitted in accordance with section 356c of this title is, or has been in the last 5 years, listed on the drug shortage list under section 356e of this title, or that is described in section 355(j)(11)(A) of this title, a copy of the report shall be sent promptly to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages.

If the officer or employee making any such inspection of a factory, warehouse, or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained.

(d) Analysis of samples furnished owner

Whenever in the course of any such inspection of a factory or other establishment where food is manufactured, processed, or packed, the officer or employee making the inspection obtains a sample of any such food, and an analysis is made of such sample for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge.

(e) Accessibility of records

Every person required under section 360i or 360j(g) of this title to maintain records and every person who is in charge or custody of such records shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records.

(f) Recordkeeping

(1) An accredited person described in paragraph (3) shall maintain records documenting the training qualifications of the person and the employees of the person, the procedures used by the person for handling confidential information, the compensation arrangements made by the person, and the procedures used by the person to identify and avoid conflicts of interest. Upon the request of an officer or employee designated by the Secretary, the person shall permit the officer or employee, at all reasonable times, to have access to, to copy, and to verify, the records.

(2) Within 15 days after the receipt of a written request from the Secretary to an accredited person described in paragraph (3) for copies of records described in paragraph (1), the person shall produce the copies of the records at the place designated by the Secretary.

(3) For purposes of paragraphs (1) and (2), an accredited person described in this paragraph is a person who—

(A) is accredited under subsection ~~(g) of this section;~~ or

(A) is accredited under subsection (g); or

(B) is accredited under section 360m of this title.

(g) Inspections by accredited persons

(1) ~~Not later than one year after October 26, 2002, the~~ Secretary shall, subject to the provisions of this subsection, accredit persons for the purpose of conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III ~~devices that~~ are required in section 360(h) of this ~~title,~~ or inspections of such establishments required to register ~~pursuant to~~ section 360(i) of this title. The owner or operator of such an establishment that is eligible under paragraph (6) may, from the list published under paragraph (4), select an accredited person to conduct such inspections.

(1) The Secretary shall, subject to the provisions of this subsection, accredit persons for the purpose of conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 360(h) of this title or are inspections of such establishments required to register under section 360(i) of this title. The owner or operator of such an establishment that is eligible under paragraph (6) may, from the list published under paragraph (4), select an accredited person to conduct such inspections.

(2) ~~Not later than 180 days after October 26, 2002, the~~ Secretary shall publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1). Thereafter, the Secretary shall inform those requesting accreditation, within 60 days after the receipt of such request, whether the request for accreditation is adequate for review, and the Secretary shall promptly act on the request for accreditation. Any resulting accreditation shall state that such person is accredited to conduct inspections at device establishments identified in paragraph (1). The accreditation of such person shall specify the particular activities under this subsection for which such person is accredited. In the first year following the publication in the Federal Register of criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1), the Secretary shall accredit no more than 15 persons who request to perform duties specified in paragraph (1).

(2) The Secretary shall publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1). Thereafter, the Secretary shall inform those requesting accreditation, within 60 days after the receipt of such request, whether the request for accreditation is adequate for review, and the Secretary shall promptly act on the request for accreditation. Any resulting accreditation shall state that such person is accredited to conduct inspections at device establishments identified in paragraph (1). The accreditation of such person shall specify the particular activities under this subsection for which such person is accredited.

(3) An accredited person shall, at a minimum, meet the following requirements:

(A) Such person may not be an employee of the Federal Government.

(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer, supplier, or vendor of articles regulated under this chapter and which has no organizational, material, or financial affiliation (including a consultative affiliation) with such a manufacturer, supplier, or vendor.

(C) Such person shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation.

(D) Such person shall not engage in the design, manufacture, promotion, or sale of articles regulated under this chapter.

(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices, and such person shall agree in writing that at a minimum the person will—

(i) certify that reported information accurately reflects data reviewed, inspection observations made, other matters that relate to or may influence compliance with this chapter, and recommendations made during an inspection or at an inspection's closing meeting;

(ii) limit work to that for which competence and capacity are available;

(iii) treat information received, records, reports, and recommendations as confidential commercial or financial information or trade secret information, except such information may be made available to the Secretary;

(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited; and

(v) protect against the use, in carrying out paragraph (1), of any officer or employee of the accredited person who has a financial conflict of interest regarding any product regulated under this chapter, and annually make available to the public disclosures of the extent to which the accredited person, and the officers and employees of the person, have maintained compliance with requirements under this clause relating to financial conflicts of interest.

(F) Such person shall notify the Secretary of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems standard referred to in paragraph (7) for any device establishment that such person inspects under this subsection not later than 30 days after such withdrawal, suspension, restriction, or expiration.

(G) Such person may conduct audits to establish conformance with the quality systems standard referred to in paragraph (7).

(4) The Secretary shall publish on the Internet site of the Food and Drug Administration a list of persons who are accredited under paragraph (2). Such list shall be updated to ensure that the identity of each accredited person, and the particular activities for which the person is accredited, is known to the public. The updating of such list shall be no later than one month after the accreditation of a person under this subsection or the suspension or withdrawal of accreditation, or the modification of the particular activities for which the person is accredited.

(5)(A) To ensure that persons accredited under this subsection continue to meet the standards of accreditation, the Secretary shall (i) audit the performance of such persons on a periodic basis through the review of inspection reports and inspections by persons designated by the Secretary to evaluate the compliance status of a device establishment and the performance of accredited persons, and (ii) take such additional measures as the Secretary determines to be appropriate.

(B) The Secretary may withdraw accreditation of any person accredited under paragraph (2), after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the standards of accreditation, poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection. The Secretary may suspend the accreditation of such person during the pendency of the process under the preceding sentence.

(6)(A) Subject to subparagraphs (B) and (C), a device establishment is eligible for ~~inspections~~ by persons accredited under paragraph (2) if the following conditions are met:

(6)(A) Subject to subparagraphs (B) and (C), a device establishment is eligible for inspection by persons accredited under paragraph (2) if the following conditions are met:

(i) The Secretary classified the results of the most recent inspection of the establishment ~~pursuant to subsection (h) or (i) of section 360 of this title~~ as "no action indicated" or "voluntary action indicated".

(i) The Secretary classified the results of the most recent inspection of the establishment as "no action indicated" or "voluntary action indicated".

(ii) With respect to ~~each inspection~~ to be conducted by an accredited ~~person—~~

(ii) With respect to inspections of the establishment to be conducted by an accredited person, the owner or operator of the establishment submits to the Secretary a notice that—

(I) provides the date of the last inspection of the establishment by the Secretary and the classification of that inspection;

~~(I)~~ the owner or operator ~~of the establishment submits~~ to ~~the Secretary a notice requesting clearance to~~ use ~~such a~~ person to conduct ~~the inspection, and~~ the ~~Secretary provides such clearance; and~~

(II) states the intention of the owner or operator to use an accredited person to conduct inspections of the establishment;

~~(II) such notice~~ identifies the accredited person ~~whom~~ the ~~establishment has selected~~ to conduct ~~the inspection,~~ and ~~the Secretary agrees to the selected accredited person.~~

(III) identifies the particular accredited person the owner or operator intends to select to conduct such inspections; and

~~(iii) With~~ respect to the devices that are manufactured, prepared, propagated, compounded, or processed ~~by the establishment, at least one of such devices is marketed~~ in the ~~United States, and the following additional conditions are met:~~

(IV) includes a certification that, with respect to the devices that are manufactured, prepared, propagated, compounded, or processed in the establishment—

(aa) at least 1 of such devices is marketed in the United States; and

~~(I) At~~ least ~~one~~ of such devices is marketed, or is intended to be marketed, in ~~one~~ or more foreign countries, ~~one~~ of which countries certifies, accredits, or otherwise recognizes the person accredited under paragraph (2) and identified under subclause ~~(II)~~ of ~~this clause.~~

(bb) at least 1 of such devices is marketed, or is intended to be marketed, in 1 or more foreign countries, 1 of which countries certifies, accredits, or otherwise recognizes the person accredited under paragraph (2) and identified under subclause (III) as a person authorized to conduct inspections of device establishments.

~~(II) The owner or operator of the establishment submits~~ to the ~~Secretary a statement that the law~~ of ~~a country in which such~~ a device ~~is marketed, or~~ is ~~intended~~ to ~~be marketed, recognizes an inspection~~ of the establishment by the Secretary, ~~and~~ not later than 30 days after receiving such ~~statement, the Secretary informs the owner or operator of the establishment that the owner or operator may submit~~ a ~~notice requesting clearance under clause (ii).~~

(B)(i) Except with respect to the requirement of subparagraph (A)(i), a device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 30 days after receiving such notice, issues a response that—

(iv)(I) In the case of an inspection to be conducted pursuant to 360(h) of this title, persons accredited under paragraph (2) did not conduct the two immediately preceding inspections of the establishment, except that the establishment may petition the Secretary for a waiver of such condition. Such a waiver may be granted only if the petition states a commercial reason for the waiver; the Secretary determines that the public health would be served by granting the waiver; and the Secretary has conducted an inspection of the establishment during the four-year period preceding the date on which the notice under clause (ii) is submitted to the Secretary. Such a waiver is deemed to be granted only if the petition states a commercial reason for the waiver; the Secretary has not determined that the public health would be served by granting the waiver; and the owner or operator of the device establishment has requested in writing, not later than 18 months following the most recent inspection of such establishment by a person accredited under paragraph (2), that the Secretary inspect the establishment and the Secretary has not conducted an inspection within 30 months after the most recent inspection. With respect to such a waiver that is granted or deemed to be granted, no additional such waiver may be granted until after the Secretary has conducted an inspection of the establishment.

(II) In the case of an inspection to be conducted pursuant to 360(i) of this title, the Secretary periodically conducts inspections of the establishment.

(B)(i) The Secretary shall respond to a notice under subparagraph (A) from a device establishment not later than 30 days after the Secretary receives the notice. Through such response, the Secretary shall (I) provide clearance under such subparagraph, and agree to the selection of an accredited person, or (II) make a request under clause (ii). If the Secretary fails to respond to the notice within such 30-day period, the establishment is deemed to have such clearance, and to have the agreement of the Secretary for such selection.

(ii) The request referred to in clause (i)(II) is—

(I) denies clearance to participate as provided under subparagraph (C); or

(II) makes a request under clause (ii).

(ii) The Secretary may request from the owner or operator of a device establishment in response to the notice under subparagraph (A)(ii) with respect to the establishment, or from the particular accredited person identified in such notice—

(I) ~~a request to the device establishment involved to submit to the Secretary~~ compliance data in accordance with clause ~~(iii);~~ or

(I) compliance data for the establishment in accordance with clause (iii)(I); or

(II) ~~a request to the establishment, or to the accredited person identified in the notice under subparagraph (A), for~~ information concerning the relationship between the ~~establishment and such accredited person, including information about the number of inspections of the establishment, or other establishments owned or operated by the~~ owner or operator of the ~~establishment, that have been conducted by~~ the accredited ~~person.~~

(II) information concerning the relationship between the owner or operator of the establishment and the accredited person identified in such notice in accordance with clause (iii)(II).

The Secretary may make both such requests.

The owner or operator of the establishment, or such accredited person, as the case may be, shall respond to such a request not later than 60 days after receiving such request.

~~(iii)~~ The compliance data to be submitted by a device establishment under clause ~~(ii)~~ are data describing whether the quality controls of the establishment have been sufficient for ensuring consistent compliance with current good manufacturing practice within the meaning of section 351(h) of this ~~title, and data otherwise describing whether the establishment has consistently been in compliance with sections 351 and 352 of this~~ title and other applicable provisions of this chapter. Such data shall include complete reports of ~~inspections~~ regarding good manufacturing practice or other quality control audits that, during the preceding ~~two-year~~ period, were conducted at the establishment by persons other than the owner or operator of the establishment, together with all other compliance data the Secretary deems necessary. Data under the preceding sentence shall demonstrate to the Secretary whether the establishment has facilitated consistent compliance by promptly correcting any compliance problems identified in such inspections.

(iii)(I) The compliance data to be submitted by the owner or operator of a device establishment in response to a request under clause (ii)(I) are data describing whether the quality controls of the establishment have been sufficient for ensuring consistent compliance with current good manufacturing practice within the meaning of section 351(h) of this title and with other applicable provisions of this chapter. Such data shall include complete reports of inspectional findings regarding good manufacturing practice or other quality control audits that, during the preceding 2-year period, were conducted at the establishment by persons other than the owner or operator of the establishment, together with all other compliance data the Secretary deems necessary. Data under the preceding sentence shall demonstrate to the Secretary whether the establishment has facilitated consistent compliance by promptly correcting any compliance problems identified in such inspections.

(II) A request to an accredited person under clause (ii)(II) may not seek any information that is not required to be maintained by such person in records under subsection (f)(1).

(iv) A device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 60 days after receiving the information requested under clause (ii), issues a response that denies clearance to participate as provided under subparagraph (C).

~~(iv) Not later than 60 days after receiving compliance data under clause (iii) from a device establishment, the Secretary shall provide or deny clearance under subparagraph (A).~~ The Secretary may deny clearance if the Secretary ~~determines that the establishment~~ has ~~failed to demonstrate consistent compliance for purposes of clause (iii). The Secretary shall provide to~~ the ~~establishment a statement of such reasons for such determination. If~~ the Secretary ~~fails to provide such statement~~ to the ~~establishment within such 60-day period,~~ the establishment ~~is deemed to have~~ such ~~clearance.~~

(C)(i) The Secretary may deny clearance to a device establishment if the Secretary has evidence that the certification under subparagraph (A)(ii)(IV) is untrue and the Secretary provides to the owner or operator of the establishment a statement summarizing such evidence.

(ii) The Secretary may deny clearance to a device establishment if the Secretary determines that the establishment has failed to demonstrate consistent compliance for purposes of subparagraph (B)(iii)(I) and the Secretary provides to the owner or operator of the establishment a statement of the reasons for such determination.

(v)(I) A request to an accredited person under clause (ii)(II) may not seek any information that is not required to be maintained by such person in records under subsection (f)(1) of this section. Not later than 60 days after receiving the information sought by the request, the Secretary shall agree to, or reject, the selection of such person by the device establishment involved. The Secretary may reject the selection if the Secretary provides to the establishment a statement of the reasons for such rejection. Reasons for the rejection may include that the establishment or the accredited person, as the case may be, has failed to fully respond to the request, or that the Secretary has concerns regarding the relationship between the establishment and such accredited person. ~~If within such 60-day period the Secretary fails to agree to or reject the selection in accordance with this subclause, the Secretary is deemed to have agreed to the selection.~~

(iii)(I) The Secretary may reject the selection of the accredited person identified in the notice under subparagraph (A)(ii) if the Secretary provides to the owner or operator of the establishment a statement of the reasons for such rejection. Reasons for the rejection may include that the establishment or the accredited person, as the case may be, has failed to fully respond to the request, or that the Secretary has concerns regarding the relationship between the establishment and such accredited person.

(II) If the Secretary rejects the selection of an accredited person by a device establishment, the ~~establishment~~ may make an additional selection of an accredited person by submitting to the Secretary a notice that identifies the additional selection. Clauses (i) and ~~(ii),~~ and subclause (I) of this clause, apply to the selection of an accredited person through a notice under the preceding sentence in the same manner and to the same extent as such provisions apply to a selection of an accredited person through a notice under subparagraph ~~(A).~~

(II) If the Secretary rejects the selection of an accredited person by the owner or operator of a device establishment, the owner or operator may make an additional selection of an accredited person by submitting to the Secretary a notice that identifies the additional selection. Clauses (i) and (ii) of subparagraph (B), and subclause (I) of this clause, apply to the selection of an accredited person through a notice under the preceding sentence in the same manner and to the same extent as such provisions apply to a selection of an accredited person through a notice under subparagraph (A)(ii).

~~(vi)~~ In the case of a device establishment that ~~under clause (iv)~~ is denied clearance under ~~subparagraph (A),~~ or ~~whose~~ selection of an accredited person is rejected under clause ~~(v),~~ the Secretary shall designate a person to review the ~~findings~~ of the Secretary under such clause if, during the 30-day period beginning on the date on which the establishment receives ~~the findings,~~ the ~~establishment~~ requests the review. The review shall commence not later than 30 days after the ~~establishment~~ requests the review, unless the Secretary and the ~~establishment~~ otherwise agree.

(iv) In the case of a device establishment that is denied clearance under clause (i) or (ii) or with respect to which the selection of the accredited person is rejected under clause (iii), the Secretary shall designate a person to review the statement of reasons, or statement summarizing such evidence, as the case may be, of the Secretary under such clause if, during the 30-day period beginning on the date on which the owner or operator of the establishment receives such statement, the owner or operator requests the review. The review shall commence not later than 30 days after the owner or operator requests the review, unless the Secretary and the owner or operator otherwise agree.

(C)(i) In the case of a device establishment for which the Secretary classified the results of the most recent inspection of the establishment by a person accredited under paragraph (2) as “official action indicated”, the establishment, if otherwise eligible under subparagraph (A), is eligible for further inspections by persons accredited under such paragraph if (I) the Secretary issues a written statement to the owner or operator of the establishment that the violations leading to such classification have been resolved, and (II) the Secretary, either upon the Secretary's own initiative or a petition of the owner or operator of the establishment, notifies the establishment that it has clearance to use an accredited person for the inspections. The Secretary shall respond to such petition within 30 days after the receipt of the petition.

(ii) If the Secretary denies a petition under clause (i), the device establishment involved may, after the expiration of one year after such denial, again petition the Secretary for a determination of eligibility for inspection by persons accredited by the Secretary under paragraph (2). If the Secretary denies such petition, the Secretary shall provide the establishment with such reasons for such denial within 60 days after the denial. If, as of the expiration of 48 months after the receipt of the first petition, the establishment has not been inspected by the Secretary in accordance with section 360(h) of this title, or has not during such period been inspected pursuant to section 360(i) of this title, as applicable, the establishment is eligible for further inspections by accredited persons.

(7)(A) Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment's designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report ~~(including for inspections classified as “no action indicated”)~~ in a form and manner ~~consistent with such reports prepared by employees and officials~~ designated by the Secretary to conduct ~~inspections.~~

(7)(A) Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment's designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report in a form and manner designated by the Secretary to conduct inspections, taking into consideration the goals of international harmonization of quality systems standards. Any official classification of the inspection shall be determined by the Secretary.

(B) At a minimum, an inspection report under subparagraph (A) shall identify the persons responsible for good manufacturing practice compliance at the inspected device establishment, the dates of the inspection, the scope of the inspection, and shall describe in detail each observation identified by the accredited person, identify other matters that relate to or may influence compliance with this chapter, and describe any recommendations during the inspection or at the inspection's closing meeting.

(C) An inspection report under subparagraph (A) shall be sent to the Secretary and to the designated representative of the inspected device establishment at the same time, but under no circumstances later than three weeks after the last day of the inspection. The report to the Secretary shall be accompanied by all written inspection observations previously provided to the designated representative of the establishment.

(D) Any statement or representation made by an employee or agent of a device establishment to a person accredited under paragraph (2) to conduct inspections shall be subject to section 1001 of title 18.

(E) If at any time during an inspection by an accredited person the accredited person discovers a condition that could cause or contribute to an unreasonable risk to the public health, the accredited person shall immediately notify the Secretary of the identification of the device establishment subject to inspection and such condition.

(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality systems standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.

(8) Compensation for an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services.

(9) Nothing in this subsection affects the authority of the Secretary to inspect any device establishment pursuant to this chapter.

(10)(A) For fiscal year 2005 and each subsequent fiscal year, no device establishment may be inspected during the fiscal year involved by a person accredited under paragraph (2) if—

(i) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the preceding fiscal year (referred to in this subparagraph as the “first prior fiscal year”), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such first prior fiscal year; and

(i) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the preceding fiscal year (referred to in this subparagraph as the "first prior fiscal year"), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such first prior fiscal year; and

(ii) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the fiscal year preceding the first prior fiscal year (referred to in this subparagraph as the “second prior fiscal year”), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such second prior fiscal year.

(ii) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the fiscal year preceding the first prior fiscal year (referred to in this subparagraph as the "second prior fiscal year"), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such second prior fiscal year.

(B)(i) Subject to clause (ii), the Comptroller General of the United States shall determine the amount that was obligated by the Secretary for fiscal year 2002 for compliance activities of the Food and Drug Administration with respect to devices (referred to in this subparagraph as the “compliance budget”), and of such amount, the amount that was obligated for inspections by the Secretary of device establishments (referred to in this subparagraph as the “inspection budget”).

(B)(i) Subject to clause (ii), the Comptroller General of the United States shall determine the amount that was obligated by the Secretary for fiscal year 2002 for compliance activities of the Food and Drug Administration with respect to devices (referred to in this subparagraph as the "compliance budget"), and of such amount, the amount that was obligated for inspections by the Secretary of device establishments (referred to in this subparagraph as the "inspection budget").

(ii) For purposes of determinations under clause (i), the Comptroller General shall not include in the compliance budget or the inspection budget any amounts obligated for inspections of device establishments conducted as part of the process of reviewing applications under section 360e of this title.

(iii) Not later than March 31, 2003, the Comptroller General shall complete the determinations required in this subparagraph and submit to the Secretary and the Congress a ~~reporting~~ describing the findings made through such determinations.

(iii) Not later than March 31, 2003, the Comptroller General shall complete the determinations required in this subparagraph and submit to the Secretary and the Congress a report describing the findings made through such determinations.

(i) The term “base amount” means the inspection budget determined under subparagraph (B) for fiscal year 2002.

(i) The term "base amount" means the inspection budget determined under subparagraph (B) for fiscal year 2002.

(ii) The term “adjusted base amount”, in the case of applicability to fiscal year 2003, means an amount equal to the base amount increased by 5 percent.

(ii) The term "adjusted base amount", in the case of applicability to fiscal year 2003, means an amount equal to the base amount increased by 5 percent.

(iii) The term "adjusted base amount", with respect to applicability to fiscal year 2004 or any subsequent fiscal year, means the adjusted ~~based~~ amount applicable to the preceding year increased by 5 percent.

(iii) The term "adjusted base amount", with respect to applicability to fiscal year 2004 or any subsequent fiscal year, means the adjusted base amount applicable to the preceding year increased by 5 percent.

(11) The authority provided by this subsection terminates on October 1, ~~2012.~~

(11) The authority provided by this subsection terminates on October 1, 2027.

(12) No later than four years after October 26, 2002, the Comptroller General shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate—

(A) the number of inspections ~~pursuant to subsections (h) and (i) of section 360 of this title~~ conducted by accredited persons and the number of inspections ~~pursuant to such subsections~~ conducted by Federal ~~employees;~~

(A) the number of inspections conducted by accredited persons pursuant to this subsection and the number of inspections conducted by Federal employees pursuant to section 360(h) of this title and of device establishments required to register under section 360(i) of this title;

(B) the number of persons who sought accreditation under this subsection, as well as the number of persons who were accredited under this subsection;

(D) the number of audits conducted by the Secretary of accredited persons, the quality of inspections conducted by accredited persons, whether accredited persons are meeting their obligations under this chapter, and whether the number of audits conducted is sufficient to permit these assessments;

(E) whether this subsection is achieving the goal of ensuring more information about device establishment compliance is being presented to the Secretary, and whether that information is of a quality consistent with information obtained by the Secretary pursuant to ~~subsection (h) or (i) of section 360 of this title;~~

(F) whether this subsection is advancing efforts to allow device establishments to rely upon third-party inspections for purposes of compliance with the laws of foreign governments; and

(G) whether the Congress should continue, modify, or terminate the program under this subsection.

(13) The Secretary shall include in the annual report required under section 393(g) of this title the names of all accredited persons and the particular activities under this subsection for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year.

(14) Notwithstanding any provision of this subsection, this subsection does not have any legal effect on any agreement described in section 383(b) of this title between the Secretary and a foreign country.

(15)(A) Notwithstanding any other provision of this subsection, the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of conducting inspections of—

(i) establishments that manufacture, prepare, propagate, compound, or process devices (other than types of devices licensed under section 262 of title 42), as required under section 360(h) of this title; or

(ii) establishments required to register pursuant to section 360(i) of this title.

(B) Nothing in this paragraph affects—

(i) the authority of the Secretary to inspect any device establishment pursuant to this chapter; or

(ii) the authority of the Secretary to determine the official classification of an inspection.

(h) Improvements to inspections process for device establishments

(1) In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of August 18, 2017, and update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such uniform processes and standards shall provide for—

(A) exceptions to such processes and standards, as appropriate;

(B) announcing the inspection of the establishment within a reasonable time before such inspection occurs, including by providing to the owner, operator, or agent in charge of the establishment a notification regarding the type and nature of the inspection;

(C) a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of some records that will be requested; and

(D) regular communications during the inspection with the owner, operator, or agent in charge of the establishment regarding inspection status, which may be recorded by either party with advance notice and mutual consent.

(2)(A) The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request.

(B) A request described in this subparagraph is a request for feedback—

(i) that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and

(ii) with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection (b) that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues (as determined by the Secretary).

(3) Nothing in this subsection affects the authority of the Secretary to conduct inspections otherwise permitted under this chapter in order to ensure compliance with this chapter.

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Versions

Dec 29, 2022 – presentcurrentviewing
Annual edition
Subsec. (a)(1). Pub. L. 117–328, § 3611(a), substituted “devices” for “restricted devices” in two places.
▸ what changed
Source credit
Pub. L. 117–328, div. FF, title II, § 2515(a)(2), title III, §§ 3106, 3504, 3611(a), (b)(1), 3612(a), 3613(b), Dec. 29, 2022, 136 Stat. 5806, 5807, 5859, 5869, 5872.
Dec 16, 2022 – Dec 29, 2022
OLRC release point
Subsec. (a)(1). Pub. L. 117–328, § 3611(a), substituted “devices” for “restricted devices” in two places.
▸ what changed changes vs current →
Source credit
Pub. L. 117–229, div. C, title III, § 306, Dec. 16, 2022, 136 Stat. 2312
Sep 30, 2022 – Dec 16, 2022
OLRC release point
Subsec. (a)(1). Pub. L. 117–328, § 3611(a), substituted “devices” for “restricted devices” in two places.
▸ what changed changes vs current →
Source credit
Pub. L. 117–180, div. F, title V, § 5007, Sept. 30, 2022, 136 Stat. 2168
Mar 27, 2020 – Sep 30, 2022
Annual edition
Subsec. (b). Pub. L. 116–136, § 3112(d)(1), as amended by Pub. L. 117–328, § 2515(a)(2), designated existing provisions as par. (1), redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), and added par. (2).
CARES Act →
▸ what changed changes vs current →
Source credit
Pub. L. 116–136, div. A, title III, § 3112(d), Mar. 27, 2020, 134 Stat. 362
Aug 18, 2017 – Mar 27, 2020
OLRC release point
Subsec. (g)(11). Pub. L. 115–52, § 703, substituted “October 1, 2022” for “October 1, 2017”.
▸ what changed changes vs current →
Source credit
Pub. L. 115–52, title VII, §§ 702(a), 703, 705, Aug. 18, 2017, 131 Stat. 1055–1057
Jul 9, 2012 – Aug 18, 2017
Annual edition
Subsec. (a)(4). Pub. L. 112–144, § 706, added par. (4).
▸ what changed changes vs current →
Source credit
Pub. L. 112–144, title VI, § 612, title VII, § 706, July 9, 2012, 126 Stat. 1060, 1067
Jan 4, 2011 – Jul 9, 2012
Annual edition
Subsec. (a)(1). Pub. L. 111–353, which directed the amendment of subsec. (a)(1)(B) by substituting “section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to” for “section 350c of this title when” and all that follows through “subject to”, was executed by making the substitution for “section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to” in the sentence following subpar. (B) of subsec. (a)(1), to reflect the probable intent of Congress.
▸ what changed changes vs current →
Source credit
Pub. L. 111–353, title I, § 101(b), Jan. 4, 2011, 124 Stat. 3887
Jun 22, 2009 – Jan 4, 2011
Annual edition
Subsec. (a)(1). Pub. L. 111–31, § 103(i)(1)(C), substituted “devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products” for “and devices and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) section 360i, or 360j(g) of this title, and data relating to other drugs or devices”.
▸ what changed changes vs current →
Source credit
Pub. L. 111–31, div. A, title I, § 103(i), June 22, 2009, 123 Stat. 1837
Sep 27, 2007 – Jun 22, 2009
Annual edition
Subsec. (g)(1). Pub. L. 110–85, § 228(1), substituted “The Secretary” for “Not later than one year after October 26, 2002, the Secretary”.
▸ what changed changes vs current →
Source credit
Pub. L. 110–85, title II, § 228, Sept. 27, 2007, 121 Stat. 855
Apr 1, 2004 – Sep 27, 2007
Annual edition
Subsec. (g)(1). Pub. L. 108–214, § 2(b)(1)(A), in first sentence, substituted “conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 360(h) of this title or are inspections of such establishments required to register under section 360(i) of this title.” for “conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices that are required in section 360(h) of this title, or inspections of such establishments required to register pursuant to section 360(i) of this title.”
▸ what changed changes vs current →
Source credit
Pub. L. 108–214, § 2(b)(1), Apr. 1, 2004, 118 Stat. 573
Oct 26, 2002 – Apr 1, 2004
Annual edition
Subsec. (a)(1). Pub. L. 107–188, § 306(b)(1), inserted after first sentence “In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to the limitations established in section 350c(d) of this title.”
changes vs current →
Source credit
Pub. L. 107–250, title II, § 201(a), (b), Oct. 26, 2002, 116 Stat. 1602, 1609
Jun 12, 2002 – Oct 26, 2002
Amended · full text not held
Subsec. (a)(1). Pub. L. 107–188, § 306(b)(1), inserted after first sentence “In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to the limitations established in section 350c(d) of this title.”
Source credit
Pub. L. 107–188, title III, § 306(b), June 12, 2002, 116 Stat. 670
Nov 21, 1997 – Jun 12, 2002
Annual edition
Subsec. (a)(1). Pub. L. 105–115, § 412(b), substituted “prescription drugs, nonprescription drugs intended for human use,” for “prescription drugs” in two places.
▸ what changed changes vs current →
Source credit
Pub. L. 105–115, title I, § 125(b)(2)(L), title II, § 210(b), title IV, § 412(b), Nov. 21, 1997, 111 Stat. 2326, 2344, 2375
Aug 13, 1993 – Nov 21, 1997
Annual edition
Subsec. (a)(1). Pub. L. 103–80 substituted a comma for semicolon after “finished and unfinished materials” and “section 355(i) or (k)” for “section 355(i) or (j)”.
changes vs current →
Source credit
Pub. L. 103–80, § 3(aa), Aug. 13, 1993, 107 Stat. 778
Sep 26, 1980 – Aug 13, 1993
Amended · full text not held
Subsec. (a)(1). Pub. L. 96–359, § 4(1), (2), restructured first five sentences of former subsec. (a) as par. (1) and, as so restructured, inserted reference to paragraph (3) and substituted “(A)” and “(B)” for “(1)” and “(2)”, respectively.
Source credit
Pub. L. 96–359, § 4, Sept. 26, 1980, 94 Stat. 1193
May 28, 1976 – Sep 26, 1980
Amended · full text not held
Subsec. (a). Pub. L. 94–295, § 6(a)–(c), expanded existing provisions to encompass medical devices by inserting references to factories, warehouses, establishments, and consulting laboratories in which restricted devices are manufactured, processed, packed, or held, inspections relating to devices, reporting and inspection regulations issued pursuant to sections 360i and 360j(g) of this title, and the manufacture and processing of devices.
Source credit
Pub. L. 94–295, § 6, May 28, 1976, 90 Stat. 581
Oct 10, 1962 – May 28, 1976
Amended · full text not held
Subsec. (a). Pub. L. 87–781, § 201(a), extended the inspection, where prescription drugs are manufactured, processed, packed, or held, to all things bearing on whether adulterated or misbranded drugs, or any which may not be manufactured, introduced in interstate commerce, or sold or offered for sale under any provision of this chapter, have been or are being manufactured, processed, packed, transported or held in any such place, or otherwise bearing on violation of this chapter, but excluded from such inspection, data concerning finance, sales other than shipment, pricing, personnel other than qualifications of technical and professional personnel, research other than relating to new drugs subject to reporting, provided that provisions of second sentence of this subsection shall be inapplicable to pharmacies, practitioners and other persons enumerated in pars. (1) to (4), and struck out “are held” before “after such introduction”.
Source credit
Pub. L. 87–781, title II, § 201(a), (b), Oct. 10, 1962, 76 Stat. 792, 793
Aug 7, 1953 – Oct 10, 1962
Amended · full text not held
Act Aug. 7, 1953, designated existing provisions as subsec. (a) and amended them by substituting provisions permitting entry and inspection upon presentation of appropriate credentials and a written notice to the owner, operator, or agent in charge for provisions which authorized entry and inspection only after making a request and obtaining permission from the owner, operator, or custodian, and inserting provisions requiring a separate written notice for each inspection but not for each entry made during the period covered by the inspection, and directing that the inspection shall be conducted within reasonable limits, in a reasonable manner and completed with reasonable promptness, and added subsecs. (b) to (d).
Source credit
Aug. 7, 1953, ch. 350, § 1, 67 Stat. 476
Jun 25, 1938 – Aug 7, 1953
Enacted · full text not held
Source credit
June 25, 1938, ch. 675, § 704, 52 Stat. 1057

See all changes since 1993 → current

Every enactment and amendment in this section's credit is listed. Full text is shown for versions back to 1993; earlier amendments are recorded by date and act, without pre-1994 full text.