§1.1154. What other records requirements must a LAAF-accredited laboratory meet? — Inbound Citations

(e) 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.

(c) A recognized accreditation body must not prevent or interfere with FDA's access to the records the LAAF-accredited laboratories it LAAF-accredits are required to maintain under § 1.1154.

(a) A LAAF-accredited laboratory must notify FDA and its recognized accreditation body at least 60 calendar days before voluntarily relinquishing LAAF-accreditation or any method within the scope of LAAF-accreditation. The notice must include the date on which relinquishment will occur. If the laboratory will relinquish all methods within its scope of LAAF-accreditation, the notification must also include the name and contact information of the custodian who will maintain the records required by § 1.1154 after the date of relinquishment. The contact information for the records custodian must include an email address and the street address where the records required by § 1.1154 will be located.

(d) Within 10 business days of the date of issuance of disqualification, the laboratory must provide the name and email address of the custodian who will maintain and make available to FDA the records required by § 1.1154, and the street address where the records will be located.

(1) The LAAF-accredited laboratory must submit to FDA documentation of the LAAF-accredited laboratory's most recent internal audit, required under § 1.1154(a)(5), documentation showing compliance with the conflict of interest requirements in § 1.1147, and documentation of the most recent proficiency test or comparison program result for each test method within the laboratory's scope of LAAF-accreditation, to show compliance with § 1.1138(a)(2); and