When must a recognized accreditation body require corrective action, suspend a LAAF-accredited laboratory, or reduce the scope of or withdraw the LAAF-accreditation of a laboratory?
21 C.F.R. § 1.1121
in effectEffective: 2024-07-01(a) Corrective action. A recognized accreditation body may require corrective action using the procedures described by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 8.7 to address any deficiencies identified while assessing and overseeing a LAAF-accredited laboratory.
(1) The recognized accreditation body must 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 the recognized accreditation body for approval.
(2) The LAAF-accredited laboratory must implement appropriate corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit the results of the corrective action to the recognized accreditation body.
(3) The recognized accreditation body will review the corrective action and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
(b) Suspension. If a recognized accreditation body determines that a laboratory it LAAF-accredits has not effectively implemented corrective action or otherwise fails to address deficiencies identified, the recognized accreditation body may temporarily suspend the LAAF-accredited laboratory for one or more LAAF-accredited methods, and require corrective action under paragraph (a) of this section.
(1) The recognized accreditation body must notify the LAAF-accredited laboratory of the grounds for the suspension, the LAAF-accredited methods subject to the suspension, and all deficiencies that must be addressed via the process described in paragraph (a) of this section.
(2) The recognized accreditation body must notify FDA of the suspension under this section in accordance with the requirements of § 1.1123(d)(5). FDA will provide notice of the LAAF-accredited laboratory's suspension on the website described in § 1.1109.
(3) The recognized accreditation body will review the corrective action required under paragraph (b) of this section and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
(4) A LAAF-accredited laboratory shall remain suspended until it demonstrates to the recognized accreditation body's satisfaction that the LAAF-accredited laboratory has successfully implemented appropriate corrective action.
(5) If the recognized accreditation body determines that a LAAF-accredited laboratory on suspension has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, the recognized accreditation body may reduce the scope of or withdraw the LAAF-accreditation of the laboratory under paragraph (c) of this section.
(c) Reduction of scope or withdrawal of LAAF-accreditation. A recognized accreditation body must reduce the scope of or withdraw the LAAF-accreditation of a laboratory it LAAF-accredits when the laboratory substantially fails to comply with this subpart. When only certain methods within the laboratory's scope of LAAF-accreditation are affected by the noncompliance, the recognized accreditation body may reduce the scope of the laboratory's LAAF-accreditation for only those affected methods. If all methods are affected, the recognized accreditation body must withdraw the laboratory's LAAF-accreditation.
(d) Procedures for reduction of scope or withdrawal of LAAF-accreditation. (1) The recognized accreditation body must notify the laboratory of any reduction of scope or withdrawal of LAAF-accreditation, including:
(i) The grounds for the reduction of scope or withdrawal of LAAF-accreditation;
(ii) The method(s) to which the reduction of scope applies;
(iii) The procedures for appealing the reduction of scope or withdrawal of LAAF-accreditation as described in § 1.1122; and
(iv) The date the reduction of scope or withdrawal of LAAF-accreditation is effective.
(2) The recognized accreditation body must notify FDA of the reduction of scope or withdrawal of LAAF-accreditation under this section in accordance with the requirements in § 1.1123(d)(4). FDA will provide notice of the reduction of scope or withdrawal of the laboratory's LAAF-accreditation on the website described in § 1.1109.
(e) Records request associated with suspension, reduction of scope, or withdrawal of LAAF-accreditation. To assist the recognized accreditation body in determining whether a suspension, reduction of scope, or withdrawal of LAAF-accreditation is warranted under this section, the recognized accreditation body may require the submission of records that the LAAF-accredited laboratory is required to maintain under § 1.1154.
(f) Consequences of suspension, reduction of scope, or withdrawal of LAAF-accreditation. (1) A LAAF-accredited laboratory may not conduct food testing under this subpart using suspended methods.
(2) If the recognized accreditation body withdraws the laboratory's LAAF-accreditation, the laboratory is immediately ineligible to conduct any food testing under this subpart. If the recognized accreditation body reduces the laboratory's scope of LAAF-accreditation, the laboratory is immediately ineligible to use the methods to which the reduction of scope applies to conduct food testing under this subpart.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026