---
kind: "section"
citation: "21 C.F.R. § 1.641"
title: "21"
number: "1.641"
heading: "What legal authority must a third-party certification body have to qualify for accreditation?"
url: "https://uscodex.org/cfr/21/1.641"
---

# §1.641. What legal authority must a third-party certification body have to qualify for accreditation?

- (a) A third-party certification body seeking accreditation from a recognized accreditation body or from FDA must demonstrate that it has the authority (as a governmental entity or as a legal entity with contractual rights) to perform such examinations of facilities, their process(es), and food(s) as are necessary to determine compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, and conformance with applicable industry standards and practices and to issue certifications where appropriate based on a review of the findings of such examinations. This includes authority to:
  - (1) Review any relevant records;
  - (2) Conduct onsite audits of an eligible entity; and
  - (3) **Suspend or withdraw certification for failure to comply with applicable requirements.**
- (b) A third-party certification body seeking accreditation must demonstrate that it is capable of exerting the authority (as a governmental entity or as legal entity with contractual rights) necessary to meet the applicable requirements of accreditation under this subpart if accredited.

## Notes

### Source

Source: 80 FR 74650, Nov. 27, 2015, 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.