---
kind: "section"
citation: "21 C.F.R. § 1.1141"
title: "21"
number: "1.1141"
heading: "What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?"
url: "https://uscodex.org/cfr/21/1.1141"
---

# §1.1141. What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?


If a recognized accreditation body has its application for renewal of recognition denied, relinquishes its recognition or allows its recognition to expire, or has its recognition revoked, any laboratory LAAF-accredited by the accreditation body must take either the actions in [paragraph (a)](#a) of this section or the action in [paragraph (b)](#b) of this section no later than 30 calendar days after receiving the notice to the LAAF-accredited laboratory required under [§ 1.1115(g)](/cfr/21/1.1115.md?p=g), [§ 1.1116(b)](/cfr/21/1.1116.md?p=b), or [§ 1.1131(d)(2)](/cfr/21/1.1131.md?p=d-2):

- (a)
  - (1) The LAAF-accredited laboratory must submit to FDA documentation of the LAAF-accredited laboratory's most recent internal audit, required under [§ 1.1154(a)(5)](/cfr/21/1.1154.md?p=a-5), documentation showing compliance with the conflict of interest requirements in [§ 1.1147](/cfr/21/1.1147.md), and documentation of the most recent proficiency test or comparison program result for each test method within the laboratory's scope of LAAF-accreditation, to show compliance with [§ 1.1138(a)(2)](/cfr/21/1.1138.md?p=a-2); and
  - (2) The laboratory must become LAAF-accredited by another recognized accreditation body before the laboratory's ISO/IEC 17025:2017(E) (incorporated by reference, see [§ 1.1101](/cfr/21/1.1101.md)) accreditation lapses or not later than 1 year after the LAAF-accredited laboratory receives the applicable notice under [§ 1.1115(g)](/cfr/21/1.1115.md?p=g), [§ 1.1116(b)](/cfr/21/1.1116.md?p=b), or [§ 1.1131(d)(2)](/cfr/21/1.1131.md?p=d-2), whichever is sooner.
- (b) The LAAF-accredited laboratory initiates relinquishment of its LAAF-accreditation under [§ 1.1140](/cfr/21/1.1140.md), with the relinquishment to occur within 90 calendar days.

## Notes

### Source

Source: 86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, 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.