# 21 U.S.C. § 374: Inspection

> Federal · Statutes · In force

URL: https://www.frixlaw.com/law-library/statutes/usc_t21_s374

## Section

- **Citation:** 21 U.S.C. § 374
- **Heading:** Inspection
- **Jurisdiction:** Federal
- **Kind:** Statutes
- **Status:** In force
- **Text as of:** April 17, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—FOOD AND DRUGS > CHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII—GENERAL AUTHORITY > Part A—General Administrative Provisions

## Text

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.

( 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 ; Pub. L. 116–136, div. A, title III, § 3112(d) , Mar. 27, 2020 , 134 Stat. 362 ; Pub. L. 117–180, div. F, title V, § 5007 , Sept. 30, 2022 , 136 Stat. 2168 ; Pub. L. 117–229, div. C, title III, § 306 , Dec. 16, 2022 , 136 Stat. 2312 ; 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.)

## Nearby sections

- [21 U.S.C. § 371 Regulations and hearings](https://www.frixlaw.com/law-library/statutes/usc_t21_s371.md)
- [21 U.S.C. § 372 Examinations and investigations](https://www.frixlaw.com/law-library/statutes/usc_t21_s372.md)
- [21 U.S.C. § 372a Transferred](https://www.frixlaw.com/law-library/statutes/usc_t21_s372a.md)
- [21 U.S.C. § 373 Records](https://www.frixlaw.com/law-library/statutes/usc_t21_s373.md)
- [21 U.S.C. § 374 Inspection](https://www.frixlaw.com/law-library/statutes/usc_t21_s374.md)
- [21 U.S.C. § 374a Inspections relating to food allergens](https://www.frixlaw.com/law-library/statutes/usc_t21_s374a.md)
- [21 U.S.C. § 375 Publicity](https://www.frixlaw.com/law-library/statutes/usc_t21_s375.md)
- [21 U.S.C. § 376 Examination of sea food on request of packer; marking food with results; fees; penalties](https://www.frixlaw.com/law-library/statutes/usc_t21_s376.md)
- [21 U.S.C. § 377 Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests](https://www.frixlaw.com/law-library/statutes/usc_t21_s377.md)
- [21 U.S.C. § 378 Advertising of foods](https://www.frixlaw.com/law-library/statutes/usc_t21_s378.md)
- [21 U.S.C. § 379 Confidential information](https://www.frixlaw.com/law-library/statutes/usc_t21_s379.md)
- [21 U.S.C. § 379a Presumption of existence of jurisdiction](https://www.frixlaw.com/law-library/statutes/usc_t21_s379a.md)
- [21 U.S.C. § 379aa Serious adverse event reporting for nonprescription drugs](https://www.frixlaw.com/law-library/statutes/usc_t21_s379aa.md)
- [21 U.S.C. § 379aa–1 Serious adverse event reporting for dietary supplements](https://www.frixlaw.com/law-library/statutes/usc_t21_s379aa%E2%80%931.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/usc_t21_s374. Check the current official text before relying on it. Not legal advice.