§ 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?

§ 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) section 7.9, implement appropriate corrective action under ISO/IEC 17025:2017(E) section 8.7, 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) 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) of this section.

(2) FDA will provide notice of a LAAF-accredited laboratory's probation on the website described in § 1.1109.

(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) 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; and

(v) The procedures for requesting reinstatement after disqualification under § 1.1142.

(2) FDA will provide notice of a LAAF-accredited laboratory's disqualification on the website described in § 1.1109.