Code of Federal Regulations Title 21. Food and Drugs § 21.1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?

(a) A recognized accreditation body must annually conduct a comprehensive assessment of the performance of each third-party certification body it accredited under this subpart by reviewing the accredited third-party certification body's self-assessments (including information on compliance with the conflict of interest requirements of §§ 1.643 and 1.657);  its regulatory audit reports and notifications submitted to FDA under § 1.656;  and any other information reasonably available to the recognized accreditation body regarding the compliance history of eligible entities the accredited third-party certification body certified under this subpart;  or that is otherwise relevant to a determination whether the accredited third-party certification body is in compliance with this subpart.

(b) No later than 1 year after the initial date of accreditation of the third-party certification body and every 2 years thereafter for duration of its accreditation under this subpart, a recognized accreditation body must conduct onsite observations of a representative sample of regulatory audits performed by the third-party certification body (or its audit agents) (or, in the case of a third-party certification body that is an individual, such individual) accredited under this subpart and must visit the accredited third-party certification body's headquarters (or other location that manages audit agents conducting food safety audits under this subpart, if different than its headquarters). The recognized accreditation body will consider the results of such observations and visits in the annual assessment of the accredited third-party certification body required by paragraph (a) of this section.