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(a) Corrective action. FDA may require corrective action to address any deficiencies identified while evaluating a recognized accreditation body under this subpart.
(1) FDA will notify the recognized accreditation body of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the recognized accreditation body to submit a corrective action plan and timeframe for implementation to FDA for approval.
(2) The recognized accreditation body must handle FDA's notification as a complaint under ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) section 7.12, implement appropriate corrective action under ISO/IEC 17011:2017(E) section 9.5, 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 recognized accreditation body whether the corrective action is acceptable.
(b) Probation. If FDA determines that a recognized accreditation body has not effectively implemented corrective action or otherwise fails to address deficiencies identified, FDA may put the recognized accreditation body on probation and require corrective action under paragraph (a) of this section.
(1) FDA will notify the recognized accreditation body of the grounds for the probation and all deficiencies requiring corrective action via the process described in paragraph (a) of this section.
(2) FDA will notify all laboratories LAAF-accredited by the recognized accreditation body that the recognized accreditation body is on probation and will provide notice of the probation on the website described in § 1.1109.
(3) FDA will review the corrective action and will notify the recognized accreditation body whether the corrective action is acceptable.
(4) A recognized accreditation body shall remain on probation until the recognized accreditation body demonstrates to FDA's satisfaction that it has successfully implemented appropriate corrective action.
(5) If FDA determines that a recognized accreditation body on probation has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, FDA may revoke recognition of the recognized accreditation body under paragraph (c) of this section.
(c) Revocation of recognition. FDA will revoke the recognition of an accreditation body if it fails to meet the requirements of this subpart, if FDA determines the accreditation body has committed fraud or submitted material false statements to FDA, or if FDA determines that a recognized accreditation body on probation has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified.
(d) Revocation of recognition procedures. (1) FDA will issue a notice of revocation of recognition to the recognized accreditation body that will include the grounds for revocation, the date on which revocation is effective, the procedures for requesting a regulatory hearing on the revocation under § 1.1173, and the procedures for requesting reinstatement of recognition under § 1.1117.
(2) FDA will notify all laboratories LAAF-accredited by the recognized accreditation body that recognition has been revoked and will provide notice of the revocation of recognition of an accreditation body on the website described in § 1.1109.
(3) Within 10 business days of the date of issuance of revocation, the accreditation body must provide the name and contact information of the custodian who will maintain records and make them available to FDA as required by § 1.1124. The contact information must include an email address for the records custodian and the street address where the records required by § 1.1124 will be located.
(e) Effect of probation or revocation of recognition on the accreditation body. (1) A recognized accreditation body that is put on probation by FDA must continue to oversee laboratories that it has LAAF-accredited under this subpart and may continue to LAAF-accredit laboratories under § 1.1120.
(2) An accreditation body that has had its recognition revoked by FDA may not LAAF-accredit laboratories under this subpart or continue to oversee the laboratories it has previously LAAF-accredited while the accreditation body is not recognized.
[86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022]
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