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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Part 1 - General Enforcement Regulations |
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Subpart M - Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications |
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Accreditation of Third-Party Certification Bodies Under This Subpart |
§ 1.641 - What legal authority must a third-party certification body have to qualify for accreditation?
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§ 1.641 What legal authority must a third-party certification body have to qualify for accreditation?
(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.