---
kind: "section"
citation: "21 C.F.R. § 1.1161"
title: "21"
number: "1.1161"
heading: "When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?"
url: "https://uscodex.org/cfr/21/1.1161"
---

# §1.1161. When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?

- (a) **Corrective action.** FDA may require corrective action to address any deficiencies identified while reviewing a LAAF-accredited laboratory's performance under this subpart.
  - (1) FDA will notify the LAAF-accredited laboratory of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the LAAF-accredited laboratory to submit a corrective action plan and timeframe for implementation to FDA for approval.
  - (2) The LAAF-accredited laboratory must handle FDA's notification as a complaint under ISO/IEC 17025:2017(E) (incorporated by reference, see [§ 1.1101](/cfr/21/1.1101.md)) [section 7.9](/cfr/21/7.9.md), implement appropriate corrective action under ISO/IEC 17025:2017(E) [section 8.7](/cfr/21/8.7.md), and submit both the results of the complaint investigation and subsequent corrective action to FDA.
  - (3) FDA will review the corrective action and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
- (b) **Probation.** If FDA determines that a LAAF-accredited laboratory has not effectively implemented corrective action or otherwise fails to address deficiencies identified, FDA may put the LAAF-accredited laboratory on probation for one or more methods and require corrective action under [paragraph (a)](#a) of this section.
  - (1) FDA will notify the LAAF-accredited laboratory and its recognized accreditation body of the grounds for the probation, the method(s) covered by the probation, and all deficiencies requiring corrective action via the process described in [paragraph (a)](#a) of this section.
  - (2) FDA will provide notice of a LAAF-accredited laboratory's probation on the website described in [§ 1.1109](/cfr/21/1.1109.md).
  - (3) FDA will review the corrective action and will notify the LAAF-accredited laboratory and its recognized accreditation body whether the corrective action is acceptable.
  - (4) A LAAF-accredited laboratory will remain on probation until the LAAF-accredited laboratory demonstrates to FDA's satisfaction that it has successfully implemented appropriate corrective action.
  - (5) If FDA determines that a LAAF-accredited laboratory on probation has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, FDA may disqualify the LAAF-accredited laboratory under [paragraph (c)](#c) of this section.
- (c) **Disqualification.** FDA may disqualify a LAAF-accredited laboratory from submitting analytical reports under this subpart for one or more methods for good cause, which may include any of the following reasons:
  - (1) **Deliberate falsification of analytical reports, testing results, or other records submitted to FDA.**
  - (2) Failure of a LAAF-accredited laboratory on probation to effectively implement corrective action or otherwise address identified deficiencies.
  - (3) Other failure to substantially comply with this subpart where the laboratory's recognized accreditation body has not reduced the scope of or withdrawn LAAF-accreditation of the laboratory.
- (d) **Disqualification procedures.**
  - (1) FDA will issue a notice of disqualification to a LAAF-accredited laboratory and its recognized accreditation body, which will include:
    - (i) The grounds for disqualification;
    - (ii) The method or methods to which the disqualification applies;
    - (iii) The date the disqualification will be effective;
    - (iv) The procedures for requesting a regulatory hearing on the disqualification under [§ 1.1173](/cfr/21/1.1173.md); and
    - (v) The procedures for requesting reinstatement after disqualification under [§ 1.1142](/cfr/21/1.1142.md).
  - (2) FDA will provide notice of a LAAF-accredited laboratory's disqualification on the website described in [§ 1.1109](/cfr/21/1.1109.md).

## 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.