§1.621. How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited? — Inbound Citations
21 C.F.R. § 1.621
Statutory Authority
Cited by 7 regulations in release Current.
Citations to 21 C.F.R. § 1.621 as a whole
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(a) A recognized accreditation body must submit to FDA electronically, in English, a report of the results of any assessment conducted under § 1.621, no later than 45 days after completing such assessment. The report must include an up-to-date list of any audit agents used by the accredited third-party certification body to conduct food safety audits under this subpart.
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(4) Its monitoring of accredited third-party certification bodies under § 1.621;
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(6) Allow FDA and the recognized accreditation body that accredited such third-party certification body, if any, to observe any food safety audit conducted under this subpart for purposes of evaluating the accredited third-party certification body's performance under §§ 1.621 and 1.662 or, where appropriate, the recognized accreditation body's performance under §§ 1.622 and 1.633.
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(4) Actions taken in response to the results of any assessments conducted by FDA or, where applicable, the recognized accreditation body under § 1.621; and
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(3) Reports of assessments by a recognized accreditation body under § 1.621;
Citations to §1.621(b)
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(b) As a means to evaluate the recognized accreditation body's performance, the self-assessment must include onsite observation of regulatory audits of a representative sample of third-party certification bodies it accredited under this subpart. In meeting this requirement, the recognized accreditation body may use the results of onsite observations performed under § 1.621(b).