§ 1.1154 - What other records requirements must a LAAF-accredited laboratory meet?

§ 1.1154 What other records requirements must a LAAF-accredited laboratory meet?

(a) In addition to the records requirements of § 1.1138(a), a LAAF-accredited laboratory must maintain, for 5 years after the date of creation, records created and received while it is LAAF-accredited that relate to compliance with this subpart, including:

(1) Documents related to the LAAF-accredited laboratory's grant of LAAF-accreditation (and, if applicable, extensions and reductions of scope of LAAF-accreditation) from its recognized accreditation body, including all required proficiency test and comparison program records for each method within the scope of LAAF-accreditation under § 1.1138(a)(2);

(2) Documentation of food testing the LAAF-accredited laboratory conducted under this subpart sufficient to account for all information required by § 1.1152(d), in accordance with § 1.1150(d);

(3) All documents that the LAAF-accredited laboratory was required to submit to FDA under §§ 1.1152 and 1.1153, and associated correspondence between the LAAF-accredited laboratory (and its officers, employees, and other agents) and the owner or consignee (and its officers, employees, and other agents) regarding food testing under this subpart;

(4) All requests for food testing from an owner or consignee that would be conducted under this subpart;

(5) Documentation of any internal investigations, internal audits, and corrective action taken to address any problems or deficiencies related to activities under this subpart;

(6) All documentation related to suspension, probation, reduction of scope, or withdrawal of LAAF-accreditation, or laboratory disqualification under this subpart; and

(7) Documentation of changes to its management system or food testing activities that may affect its compliance with this subpart.

(b) Make the records required by paragraph (a) of this section available for inspection and copying or for electronic submission upon written request of an authorized officer or employee of FDA. If FDA requests records for inspection and copying, the laboratory must make such records promptly available at the physical location of the laboratory or at another reasonably accessible location. If the authorized officer or employee of FDA requests electronic submission, the records must be submitted within 10 business days of the request.

(c) Ensure that significant amendments to records described by this section can be tracked to previous and original versions. If such a significant amendment is made, both the original document and amended document must be maintained by the LAAF-accredited laboratory during the time period for which the amended document must be maintained under this subpart. The laboratory must also document the date of amendment, the personnel responsible for the amendment, and a conspicuous indication on the original document stating that the document has been altered and that a more recent version of the document exists.