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Code · CFR · Title 21 — Food and Drugs · Part 1 — General Enforcement Regulations · § 1.680

§ 1.680. How and when will FDA monitor eligible entities?

83 words·~1 min read·/us/cfr/t21/s§ 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.
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