Code of Federal Regulations · Section
§ 1.680 — How And When Will Fda Monitor Eligible Entities?
21 C.F.R. § 1.680
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FDA may, at any time, conduct an onsite audit of an eligible entity that has received food or facility certification from an accredited third-party certification body under this subpart. Where FDA determines necessary or appropriate, the unannounced audit may be conducted with or without the accredited third-party certification body or the recognized accreditation body (where applicable) present. An FDA audit conducted under this section will be conducted on an unannounced basis and may be preceded by a request for a 30-day operating schedule.
Authorizing Statute
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General orders19 U.S.C. § 1490
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Definitions; generally21 U.S.C. § 321
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Labeling15 U.S.C. § 1333
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Regulations42 U.S.C. § 216