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21 CFR 1.641

§ 1.641 What legal authority must a third-party certification body have to qualify for accreditation?

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 1.641, § 1.641 What legal authority must a third-party certification body have to qualify for accreditation?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/82840
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(a) A third-party certification body seeking accreditation from a recognized accreditation body or from FDA must demonstrate that it has the authority (as a governmental entity or as a legal entity with contractual rights) to perform such examinations of facilities, their process(es), and food(s) as are necessary to determine compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, and conformance with applicable industry standards and practices and to issue certifications where appropriate based on a review of the findings of such examinations. This includes authority to: (1) Review any relevant records; (2) Conduct onsite audits of an eligible entity; and (3) Suspend or withdraw certification for failure to comply with applicable requirements. (b) A third-party certification body seeking accreditation must demonstrate that it is capable of exerting the authority (as a governmental entity or as legal entity with contractual rights) necessary to meet the applicable requirements of accreditation under this subpart if accredited.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.