For regulatory audits, in which a facility is examined for compliance with FDA food safety requirements for purposes of certification, an accredited third-party certification body must routinely submit an audit report to the FDA. For consultative audits, which are performed in preparation for regulatory audits and do not result in issuance of a certification, the audit report is generally intended for internal use. The FDA must be notified if a potential serious risk to public health is identified during a regulatory or consultative audit.
