Code of Federal Regulations Title 21. Food and Drugs § 21.1.658 What records requirements must a third-party certification body that has been accredited meet?

(1) Any audit report and other documents resulting from a consultative audit conducted under this subpart, including the audit agent's observations, correspondence with the eligible entity, verification of any corrective action(s) taken to address deficiencies identified during the audit;

(2) Any request for a regulatory audit from an eligible entity;

(3) Any audit report and other documents resulting from a regulatory audit conducted under this subpart, including the audit agent's observations, correspondence with the eligible entity, verification of any corrective action(s) taken to address deficiencies identified during the audit, and, when sampling and analysis is conducted, laboratory testing records and results from a laboratory that is accredited in accordance with § 1.651(b)(3), and documentation demonstrating such laboratory is accredited in accordance with § 1.651(b)(3);

(4) Any notification submitted by an audit agent to the accredited third-party certification body in accordance with § 1.650(a)(5);

(5) Any challenge to an adverse regulatory audit decision and the disposition of the challenge;

(6) Any monitoring it conducted of an eligible entity to which food or facility certification was issued;

(7) Its self-assessments and corrective actions taken to address any deficiencies identified during a self-assessment;  and

(8) Significant changes to its auditing or certification program that might affect compliance with this subpart.