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Code · CFR · Title 21 — Food and Drugs · Part 1 — General Enforcement Regulations · § 1.654

§ 1.654. When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?

131 words·~1 min read·/us/cfr/t21/s§ 1.654

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If an accredited third-party certification body has reason to believe that an eligible entity to which it issued a food or facility certification may no longer be in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, the accredited third-party certification body must conduct any monitoring (including an onsite audit) of such eligible entity necessary to determine whether the entity is in compliance with such requirements. The accredited third-party certification body must immediately notify FDA, under § 1.656(d), if it withdraws or suspends a food or facility certification because it determines that the entity is no longer in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations.
The accredited third-party certification body must maintain records of such monitoring under § 1.658.
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