[Code of Federal Regulations] |
[Title 21, Volume 1] |
[CITE: 21CFR1.680] |
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CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES |
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PART 1 -- GENERAL ENFORCEMENT REGULATIONS
Subpart M - Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
Requirements for Eligible Entities Under This Subpart
Sec. 1.680 How and when will FDA monitor eligible entities?
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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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