Title 21

SECTION 1.641

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.

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