21 U.S.C. 374: Inspection

2022

• Pub. L. 117–328, §3611(a), substituted "devices" for "restricted devices" in two places. (Consolidated Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–328, §3504, inserted "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 re… (Consolidated Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–328, §3611(b)(1), substituted "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)," for "an establishment that is eng… (Consolidated Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–328, §3613(b), added subpar. (C) and redesignated former subpar. (C) as (D). (Consolidated Appropriations Act, 2023) Law text · (a), (D)
• Pub. L. 117–328, §3612(a), added par. (5). (Consolidated Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–328, §2515(a)(2), made technical amendment to directory language of Pub. L. 116–136, §3112(d)(1). See 2020 Amendment note below. (Consolidated Appropriations Act, 2023) Law text · (b)
• Pub. L. 117–328, §3106, substituted "October 1, 2027" for "December 24, 2022". (Consolidated Appropriations Act, 2023) Law text · (g)
• Pub. L. 117–229 substituted "December 24, 2022" for "December 17, 2022". (Further Continuing Appropriations and Extensions Act, 2023) Law text · (g)
• Pub. L. 117–180 substituted "December 17" for "October 1". (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (g)

2020

• 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). (Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act) Law text · (b)

2017

• Pub. L. 115–52, §703, substituted "October 1, 2022" for "October 1, 2017". (FDA Reauthorization Act of 2017) Law text · (g)
• Pub. L. 115–52, §705, added par. (15). (FDA Reauthorization Act of 2017) Law text · (g)
• Pub. L. 115–52, §702(a), added subsec. (h). (FDA Reauthorization Act of 2017) Law text · (h)

2012

• Pub. L. 112–144, §706, added par. (4). (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §612, substituted "October 1, 2017" for "October 1, 2012". (Food and Drug Administration Safety and Innovation Act) Law text · (g)

2011

• 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 tha… (FDA Food Safety Modernization Act) Law text · (a)

2009

• 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 r… Law text · (a)
• Pub. L. 111–31, §103(i)(1)(B), substituted "restricted devices, or tobacco products" for "or restricted devices" in two places. Law text · (a)
• Pub. L. 111–31, §103(i)(1)(A), substituted "devices, tobacco products, or cosmetics" for "devices, or cosmetics" in two places. Law text · (a)
• Pub. L. 111–31, §103(i)(2), inserted "tobacco product," after "device,". Law text · (b)
• 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. Law text · (g)

2007

• Pub. L. 110–85, §228(1), substituted "The Secretary" for "Not later than one year after October 26, 2002, the Secretary". (Food and Drug Administration Amendments Act of 2007) Law text · (g)
• 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… (Food and Drug Administration Amendments Act of 2007) Law text · (g)
• Pub. L. 110–85, §228(3), added subpars. (F) and (G). (Food and Drug Administration Amendments Act of 2007) Law text · (g), (G)
• Pub. L. 110–85, §228(4), amended par. (6) generally, revising and restating provisions of former subpars. (A) to (C). (Food and Drug Administration Amendments Act of 2007) Law text · (g)
• 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 establishme… (Food and Drug Administration Amendments Act of 2007) Law text · (g)
• Pub. L. 110–85, §228(5)(B), added subpar. (F). (Food and Drug Administration Amendments Act of 2007) Law text · (g)
• Pub. L. 110–85, §228(6), substituted "base amount applicable" for "based amount applicable". (Food and Drug Administration Amendments Act of 2007) Law text · (g)

2004

• 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 su… Law text · (g)
• 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 be… Law text · (g)
• 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". Law text · (g)
• 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. Law text · (g)
• Pub. L. 108–214, §2(b)(1)(C)(ii)(II), substituted "an accredited person" for "such a person". Law text · (g)
• 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. Law text · (g)
• 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) … Law text · (g)
• Pub. L. 108–214, §2(b)(1)(C)(iii)(III), inserted "or by a person accredited under paragraph (2)" after "by the Secretary". Law text · (g)
• 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 "t… Law text · (g)
• 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". Law text · (g)
• 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 "inspectio… Law text · (g)
• Pub. L. 108–214, §2(b)(1)(E), designated existing provisions as subcl. (I) and added subcl. (II). Law text · (g)
• 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". Law text · (g)
• Pub. L. 108–214, §2(b)(1)(G), substituted "a report" for "a reporting". Law text · (g)
• 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 … Law text · (g)
• 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;". Law text · (g)

2002

• 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… (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (a)
• Pub. L. 107–188, §306(b)(2), substituted "third sentence" for "second sentence" in introductory provisions. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (a)
• 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 initia… (Medical Device User Fee and Modernization Act of 2002) Law text · (f)
• 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". (Medical Device User Fee and Modernization Act of 2002) Law text · (f)
• Pub. L. 107–250, §201(b)(3), added par. (3). (Medical Device User Fee and Modernization Act of 2002) Law text · (f)
• Pub. L. 107–250, §201(a), added subsec. (g). (Medical Device User Fee and Modernization Act of 2002) Law text · (g)

1997

• Pub. L. 105–115, §412(b), substituted "prescription drugs, nonprescription drugs intended for human use," for "prescription drugs" in two places. (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §125(b)(2)(L), struck out ", section 357(d) or (g)," before "section 360i". (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §210(b), added subsec. (f). (Food and Drug Administration Modernization Act of 1997) Law text · (f)

1993

• 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)". · (a)

1980

• 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. · (a)
• 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)", "… · (a)
• Pub. L. 96–359, §4(4), added par. (3). · (a)

1976

• 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, … · (a)
• Pub. L. 94–295, §6(d), added subsec. (e). · (e)

1962

• 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 sal… · (a)
• Pub. L. 87–781, §201(b), inserted "consulting laboratory" after "warehouse". · (b)