Source: https://casetext.com/statute/united-states-code/title-21-food-and-drugs/chapter-9-federal-food-drug-and-cosmetic-act/subchapter-vii-general-authority/part-a-general-administrative-provisions/374-inspection?ref=AsVVwS!xbIhgo
Timestamp: 2019-05-25 09:15:39
Document Index: 11293449

Matched Legal Cases: ['§ 374', '§ 374', '§ 374', '§ 374', '§ 704', '§ 1', '§ 201', '§ 6', '§ 4', '§ 3', '§ 125', '§ 210', '§ 412', '§ 306', '§ 201', '§ 2', '§ 228', '§ 103', '§ 101', '§ 612', '§ 706', '§ 702', '§ 703', '§ 705', '§ 702', '§ 706', '§ 612', '§ 103', '§ 103', '§ 103', '§ 103', '§ 103', '§ 228', '§ 228', '§ 228', '§ 228', '§ 228', '§ 228', '§ 228', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 306', '§ 306', '§ 201', '§ 201', '§ 201', '§ 201', '§ 412', '§ 125', '§ 210', '§ 4', '§ 4', '§ 4', '§ 6', '§ 6', '§ 201', '§ 201', '§ 702', '§ 201', '§ 373', '§ 374']

§ 374. Inspection, 21 U.S.C. § 374 | Casetext
21 U.S.C. § 374
§ 374. Inspection
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(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 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 requested.
(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, tobacco product, 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.
(c) Receipt for samples taken 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.
(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.
(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”).
(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—
(June 25, 1938, ch. 675, § 704, 52 Stat. 1057; Aug. 7, 1953, ch. 350, § 1, 67 Stat. 476; Pub. L. 87-781, title II, § 201(a), (b), Oct. 10, 1962, 76 Stat. 792, 793; Pub. L. 94-295, § 6, May 28, 1976, 90 Stat. 581; Pub. L. 96-359, § 4, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 103-80, § 3(aa), Aug. 13, 1993, 107 Stat. 778; 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; Pub. L. 107-188, title III, § 306(b), June 12, 2002, 116 Stat. 670; Pub. L. 107-250, title II, § 201(a), (b), Oct. 26, 2002, 116 Stat. 1602, 1609; Pub. L. 108-214, § 2(b)(1), Apr. 1, 2004, 118 Stat. 573; Pub. L. 110-85, title II, § 228, Sept. 27, 2007, 121 Stat. 855; Pub. L. 111-31, div. A, title I, § 103(i), June 22, 2009, 123 Stat. 1837; Pub. L. 111-353, title I, § 101(b), Jan. 4, 2011, 124 Stat. 3887; Pub. L. 112-144, title VI, § 612, title VII, § 706, July 9, 2012, 126 Stat. 1060, 1067; Pub. L. 115-52, title VII, §§ 702(a), 703, 705, Aug. 18, 2017, 131 Stat. 1055-1057.) 2017—Subsec. (g)(11). Pub. L. 115-52, § 703, substituted “October 1, 2022” for “October 1, 2017”. Subsec. (g)(15). Pub. L. 115-52, § 705, added par. (15). Subsec. (h). Pub. L. 115-52, § 702(a), added subsec. (h). 2012—Subsec. (a)(4). Pub. L. 112-144, § 706, added par. (4). Subsec. (g)(11). Pub. L. 112-144, § 612, substituted “October 1, 2017” for “October 1, 2012”. 2011—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. 2009—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”. Pub. L. 111-31, § 103(i)(1)(B), substituted “restricted devices, or tobacco products” for “or restricted devices” in two places. Subsec. (a)(1)(A). Pub. L. 111-31, § 103(i)(1)(A), substituted “devices, tobacco products, or cosmetics” for “devices, or cosmetics” in two places. Subsec. (b). Pub. L. 111-31, § 103(i)(2), inserted “tobacco product,” after “device,”. Subsec. (g)(13). Pub. L. 111-31, § 103(i)(3), made technical amendment to reference in original act which appears in text as reference to section 393(g) of this title. 2007—Subsec. (g)(1). Pub. L. 110-85, § 228(1), substituted “The Secretary” for “Not later than one year after October 26, 2002, the Secretary”. Subsec. (g)(2). Pub. L. 110-85, § 228(2), substituted “The Secretary” for “Not later than 180 days after October 26, 2002, the Secretary” and struck out at end “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).” Subsec. (g)(3)(F), (G). Pub. L. 110-85, § 228(3), added subpars. (F) and (G). Subsec. (g)(6). Pub. L. 110-85, § 228(4), amended par. (6) generally, revising and restating provisions of former subpars. (A) to (C). Subsec. (g)(7)(A). Pub. L. 110-85, § 228(5)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: “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.” Subsec. (g)(7)(F). Pub. L. 110-85, § 228(5)(B), added subpar. (F). Subsec. (g)(10)(C)(iii). Pub. L. 110-85, § 228(6), substituted “base amount applicable” for “based amount applicable”. 2004—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.” Subsec. (g)(5)(B). Pub. L. 108-214, § 2(b)(1)(B), in first sentence, substituted “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.” for “or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this subsection.” Subsec. (g)(6)(A)(i). Pub. L. 108-214, § 2(b)(1)(C)(i), substituted “described in paragraph (1)” for “of the establishment pursuant to subsection (h) or (i) of section 360 of this title”. Subsec. (g)(6)(A)(ii). Pub. L. 108-214, § 2(b)(1)(C)(ii)(I), substituted “inspections” for “each inspection” and inserted “during a 2-year period” after “person” in introductory provisions. Subsec. (g)(6)(A)(ii)(I). Pub. L. 108-214, § 2(b)(1)(C)(ii)(II), substituted “an accredited person” for “such a person”. Subsec. (g)(6)(A)(iii). Pub. L. 108-214, § 2(b)(1)(C)(iii)(I), substituted “and 1 or both of the following additional conditions are met:” for “and the following additional conditions are met:” in introductory provisions. Subsec. (g)(6)(A)(iii)(I). Pub. L. 108-214, § 2(b)(1)(C)(iii)(II), substituted “(accredited under paragraph (2) and identified under clause (ii)(II)) as a person authorized to conduct such inspections of device establishments.” for “accredited under paragraph (2) and identified under subclause (II) of this clause.” Subsec. (g)(6)(A)(iii)(II). Pub. L. 108-214, § 2(b)(1)(C)(iii)(III), inserted “or by a person accredited under paragraph (2)” after “by the Secretary”. Subsec. (g)(6)(A)(iv)(I). Pub. L. 108-214, § 2(b)(1)(C)(iv), in first sentence, inserted “section” after “pursuant to” and substituted “inspections of the establishment during the previous 4 years” for “the two immediately preceding inspections of the establishment”, in third sentence, struck out “the petition states a commercial reason for the waiver;” after “granted only if” and inserted “not” after “the Secretary has not determined that the public health would”, and, in last sentence, substituted “granted or deemed to be granted until” for “granted until”. Subsec. (g)(6)(A)(iv)(II). Pub. L. 108-214, § 2(b)(1)(C)(v), inserted “of a device establishment required to register” after “to be conducted” and “section” after “pursuant to”. Subsec. (g)(6)(B)(iii). Pub. L. 108-214, § 2(b)(1)(D), in first sentence, substituted “and with other” for “, and data otherwise describing whether the establishment has consistently been in compliance with sections 351 and 352 of this title and other” and, in second sentence, substituted “inspectional findings” for “inspections” and inserted “relevant” after “together with all other”. Subsec. (g)(6)(B)(iv). Pub. L. 108-214, § 2(b)(1)(E), designated existing provisions as subcl. (I) and added subcl. (II). Subsec. (g)(6)(C)(ii). Pub. L. 108-214, § 2(b)(1)(F), struck out “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” after “inspected by the Secretary”. Subsec. (g)(10)(B)(iii). Pub. L. 108-214, § 2(b)(1)(G), substituted “a report” for “a reporting”. Subsec. (g)(12)(A). Pub. L. 108-214, § 2(b)(1)(H)(i), added subpar. (A) and struck out former subpar. (A) which read as follows: “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;”. Subsec. (g)(12)(E). Pub. L. 108-214, § 2(b)(1)(H)(ii), substituted “obtained by the Secretary pursuant to inspections conducted by Federal employees;” for “obtained by the Secretary pursuant to subsection (h) or (i) of section 360 of this title;”. 2002—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.” Subsec. (a)(2). Pub. L. 107-188, § 306(b)(2), substituted “third sentence” for “second sentence” in introductory provisions. Subsec. (f)(1). Pub. L. 107-250, § 201(b)(1), in first sentence, substituted “An accredited person described in paragraph (3) shall maintain records” for “A person accredited under section 360m of this title to review reports made under section 360(k) of this title and make recommendations of initial classifications of devices to the Secretary shall maintain records”. Subsec. (f)(2). Pub. L. 107-250, § 201(b)(2), substituted “an accredited person described in paragraph (3)” for “a person accredited under section 360m of this title”. Subsec. (f)(3). Pub. L. 107-250, § 201(b)(3), added par. (3). Subsec. (g). Pub. L. 107-250, § 201(a), added subsec. (g). 1997—Subsec. (a)(1). Pub. L. 105-115, § 412(b), substituted “prescription drugs, nonprescription drugs intended for human use,” for “prescription drugs” in two places. Pub. L. 105-115, § 125(b)(2)(L), struck out “, section 357(d) or (g),” before “section 360i”. Subsec. (f). Pub. L. 105-115, § 210(b), added subsec. (f). 1993—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)”. 1980—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. Subsec. (a)(2). Pub. L. 96-359, § 4(3), redesignated sixth sentence of former subsec. (a) as par. (2) and, as so redesignated, substituted reference to second sentence of paragraph (1) for reference to former second sentence of this subsection, and “(A)”, “(B)”, “(C)”, and “(D)”, for “(1)”, “(2)”, “(3)”, and “(4)”, respectively. Subsec. (a)(3). Pub. L. 96-359, § 4(4), added par. (3). 1976—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. Subsec. (e). Pub. L. 94-295, § 6(d), added subsec. (e). 1962—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”. Subsec. (b). Pub. L. 87-781, § 201(b), inserted “consulting laboratory” after “warehouse”. 1953—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). Amendment by sections 210(b) and 412(b) of Pub. L. 105-115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105-115, set out as a note under section 321 of this title. Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section 203 of Pub. L. 87-781, set out as a note under section 332 of this title. Nothing in amendment by Pub. L. 111-353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title. For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. Pub. L. 115-52, title VII, § 702(b), Aug. 18, 2017, 131 Stat. 1055, provided that: “(1) Draft guidance.— Not later than 18 months after the date of enactment of this Act [Aug. 18, 2017], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance that— “(A) specifies how the Food and Drug Administration will implement the processes and standards described in paragraph (1) of subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a), and the requirements described in paragraph (2) of such subsection (h); “(B) provides for standardized methods for communications described in such paragraphs; “(C) establishes, with respect to inspections of both domestic and foreign device establishments (as referred to in section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360(h)(2)], as amended by subsection (a) [of section 701 of Pub. L. 115-52]), a standard timeframe for such inspections— “(i) that occurs over consecutive days; and “(ii) to which each investigator conducting such an inspection shall adhere unless the investigator identifies to the establishment involved a reason that more time is needed to conduct such investigation; and “(D) identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments. “(2) Final guidance.— Not later than 1 year after providing notice and opportunity for public comment on the draft guidance issued under paragraph (1), the Secretary of Health and Human Services shall issue final guidance to implement subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a).” “Within 6 months of the date of enactment of this Act [Aug. 18, 2017], the Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374). Such protocol shall— Pub. L. 87-781, title II, § 201(d), Oct. 10, 1962, 76 Stat. 793, provided that: “Nothing in the amendments made by subsections (a) and (b) of this section [amending this section] shall be construed to negate or derogate from any authority of the Secretary existing prior to the enactment of this Act [Oct. 10, 1962].”
§ 373. Records
§ 374a. Inspections relating to food allergens