How and when will FDA monitor eligible entities?

1. Law
2. CFR 21
3. Food and Drugs
4. Food and Drug Administration, Department of Health and Human Services
5. General
6. General Enforcement Regulations
7. Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
8. Requirements for Eligible Entities Under This Subpart
9. How and when will FDA monitor eligible entities?

§ 1.680 How and when will FDA monitor eligible entities?

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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