The U.S. Food and Drug Administration (FDA) released the final rule on how the FDA would recognize certification bodies commonly referred to as “auditors.” This final rule, known at the
Third-Party Accreditation Rule aims to establish a comprehensive, credible and reliable program of oversight based on third‐party audits and certification of foreign food facilities to help the FDA make decisions regarding the admissibility of imported foods.
Importantly, this rule does
set forth the exact criteria to which firms will be held accountable to during audits, as those criteria have been put forward in the NOT Produce Safety rule and the Preventive Controls Rule rule.
It’s anticipated the agency will soon be issuing important companion guidance documents for all final
rules that will provide more detailed information about coverage and compliance requirements. There will be an opportunity to provide comments on these upcoming draft guidance documents, so stay tuned.
Third-Party Accreditation Rule Summaries
FSMA Final Rule Webinars
PMA hosted a webinar series with allied associations, featuring the FDA.
FDA Resources on the Final Third-Party Accreditation Rule Comments
Third-Party Accreditation Rule Guidance Documents