---
kind: "section"
citation: "21 C.F.R. § 1.623"
title: "21"
number: "1.623"
heading: "What reports and notifications must a recognized accreditation body submit to FDA?"
url: "https://uscodex.org/cfr/21/1.623"
---

# §1.623. What reports and notifications must a recognized accreditation body submit to FDA?

- (a) **Reporting results of assessments of accredited third-party certification body performance.** A recognized accreditation body must submit to FDA electronically, in English, a report of the results of any assessment conducted under [§ 1.621](/cfr/21/1.621.md), no later than 45 days after completing such assessment. The report must include an up-to-date list of any audit agents used by the accredited third-party certification body to conduct food safety audits under this subpart.
- (b) **Reporting results of recognized accreditation body self-assessments.** A recognized accreditation body must submit to FDA electronically, in English:
  - (1) A report of the results of an annual self-assessment required under [§ 1.622](/cfr/21/1.622.md), no later than 45 days after completing such self-assessment; and
  - (2) For a recognized accreditation body subject to [§ 1.664(g)(1)](/cfr/21/1.664.md?p=g-1), a report of such self-assessment to FDA within 60 days of the third-party certification body's withdrawal. A recognized accreditation body may use a report prepared for conformance to ISO/IEC 17011:2004, supplemented as necessary, in meeting the requirements this section.
- (c) **Immediate notification to FDA.** A recognized accreditation body must notify FDA electronically, in English, immediately upon:
  - (1) Granting (including expanding the scope of) accreditation to a third-party certification body under this subpart, and include:
    - (i) The name, address, telephone number, and email address of the accredited third-party certification body;
    - (ii) The name of one or more officers of the accredited third-party certification body;
    - (iii) A list of the accredited third-party certification body's audit agents; and
    - (iv) **The scope of accreditation, the date on which it was granted, and its expiration date.**
  - (2) **Withdrawing, suspending, or reducing the scope of an accreditation under this subpart, and include—**
    - (i) The basis for such action; and
    - (ii) Any additional changes to accreditation information previously submitted to FDA under [paragraph (c)(1)](#c-1) of this section.
  - (3) Determining that a third-party certification body it accredited failed to comply with [§ 1.653](/cfr/21/1.653.md) in issuing a food or facility certification under this subpart, and include:
    - (i) The basis for such determination; and
    - (ii) Any changes to accreditation information previously submitted to FDA under [paragraph (c)(1)](#c-1) of this section.
- (d) **Other notification to FDA.** A recognized accreditation body must notify FDA electronically, in English, within 30 days after:
  - (1) **Denying accreditation (in whole or in part) under this subpart and include—**
    - (i) The name, address, telephone number, and email address of the third-party certification body;
    - (ii) The name of one or more officers of the third-party certification body;
    - (iii) The scope of accreditation requested; and
    - (iv) **The scope and basis for such denial.**
  - (2) Making any significant change that would affect the manner in which it complies with the applicable requirements of this subpart and include:
    - (i) A description of the change; and
    - (ii) **An explanation for the purpose of the change.**

## 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.