---
kind: "section"
citation: "21 C.F.R. § 1.1159"
title: "21"
number: "1.1159"
heading: "How will FDA oversee LAAF-accredited laboratories?"
url: "https://uscodex.org/cfr/21/1.1159"
---

# §1.1159. How will FDA oversee LAAF-accredited laboratories?

- (a) FDA may review the performance of LAAF-accredited laboratories at any time to determine whether the LAAF-accredited laboratory continues to comply with the applicable requirements of this subpart and whether there are deficiencies in the performance of the LAAF-accredited laboratory that, if not corrected, would warrant corrective action, probation, or disqualification under [§ 1.1161](/cfr/21/1.1161.md).
- (b) In evaluating the performance of a LAAF-accredited laboratory, FDA may review any of the following:
  - (1) Records the LAAF-accredited laboratory is required to maintain under this subpart;
  - (2) Records the recognized accreditation body that LAAF-accredited the laboratory is required to maintain under this subpart;
  - (3) Information obtained by FDA during a review of the LAAF-accredited laboratory conducted pursuant to [paragraph (c)](#c) of this section;
  - (4) Information obtained by FDA during an evaluation of the recognized accreditation body that LAAF-accredits the laboratory;
  - (5) Analytical reports and test results submitted to FDA; and
  - (6) Any other information obtained by FDA, including during FDA's inspections or investigations of one or more owners or consignees.
- (c) FDA may conduct an onsite review of a LAAF-accredited laboratory at any reasonable time, with or without a recognized accreditation body (or its officers, employees, and other agents) present, to review the performance of a LAAF-accredited laboratory under this subpart. Certain review activities may be conducted remotely if it will not aid in the review to conduct them onsite.
- (d) FDA may report any observations and deficiencies identified during its review of LAAF-accredited laboratory performance under this subpart to the recognized accreditation body.

## 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.