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Code · CFR · Title 21 — Food and Drugs · Part 1 — General Enforcement Regulations · § 1.641

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

158 words·~1 min read·/us/cfr/t21/s§ 1.641

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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.
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