21 C.F.R. · Food and Drugs
21 C.F.R. § 1.641

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

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 1.641 — What legal authority must a third-party certification body have to qualify for accreditation?

§ 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.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 1.641
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The regulatory text of 21 C.F.R. § 1.641 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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