§1.651. How must an accredited third-party certification body conduct a food safety audit of an eligible entity? — Inbound Citations

(1) Prior to issuing a food or facility certification to an eligible entity, an accredited third-party certification body (or, where applicable, an audit agent on its behalf) must complete a regulatory audit that meets the requirements of § 1.651 and any other activities that may be necessary to determine compliance with the applicable food safety requirements of the FD&C Act and FDA regulations.

(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);