Under the Preventive Controls for Human Food (PCHF) regulation (21 CFR part 117), Preventive Controls for Food for Animals (PCAF) regulation (21 CFR part 507), and Foreign Supplier Verification Programs (FSVP) regulation (21 CFR Part 1, Subpart L), receiving facilities and importers may need to conduct onsite audits to determine if their suppliers are producing food in compliance with FDA food safety standards, including the new standards promulgated under the FDA Food Safety Modernization Act (FSMA).
An annual onsite audit is required under the PCHF, PCAF, and FSVP regulations when the hazard will result in a serious adverse health consequences or death to humans or animals (SAHCODHA) and is controlled by the supplier, unless the receiving facility or importer has made a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate verification.
While onsite audits conducted to meet these supply-chain program requirements do not have to be conducted under FDA’s Accredited Third-Party Certification Program (21 CFR Part 1, Subpart M), they must be conducted by a “qualified auditor” and consider applicable food safety regulations.
These audits are often based upon food safety standards developed by third-party audit programs rather than FDA food safety requirements.
FWQRC can help determine if the third-party audit standards align with FDA food safety standards, receiving facilities and importers are responsible for meeting all the supply chain requirements in the PCHF, PCAF, and FSVP rules, including whether audits of their suppliers are conducted by qualified auditors.
If you need support for qualifying your suppliers by the qualified auditors, please contact info@fwqrc.com
