---
kind: "section"
citation: "21 C.F.R. § 1.363"
title: "21"
number: "1.363"
heading: "What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?"
url: "https://uscodex.org/cfr/21/1.363"
---

# §1.363. What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?

- (a) The failure to establish or maintain records as required by [section 414(b)](/cfr/21/414.md?p=b) of the Federal Food, Drug, and Cosmetic Act and this regulation or the refusal to permit access to or verification or copying of any such required record is a prohibited act under [section 301](/cfr/21/301.md) of the Federal Food, Drug, and Cosmetic Act.
- (b) The failure of a nontransporter immediate previous source or a nontransporter immediate subsequent recipient who enters an agreement under [§ 1.352(e)](/cfr/21/1.352.md?p=e) to establish, maintain, or establish and maintain, records required under § [1.352(a)](/cfr/21/1.352.md?p=a), [(b)](/cfr/21/1.352.md?p=b), [(c)](/cfr/21/1.352.md?p=c), or [(d)](/cfr/21/1.352.md?p=d), or the refusal to permit access to or verification or copying of any such required record, is a prohibited act under [section 301](/cfr/21/301.md) of the Federal Food, Drug, and Cosmetic Act.
- (c) The failure of any person to make records or other information available to FDA as required by section [414](/cfr/21/414.md) or [704(a)](/cfr/21/704.md?p=a) of the Federal Food, Drug, and Cosmetic Act and this regulation is a prohibited act under [section 301](/cfr/21/301.md) of the Federal Food, Drug, and Cosmetic Act.

## Notes

### Amendments

[80 FR 56144, Sept. 17, 2015

### Source

Source: 69 FR 71651, Dec. 9, 2004, unless otherwise noted.

### Authority

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

### Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

### Amendments

[80 FR 56144, Sept. 17, 2015