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SafetyChain Blog

Avoid FDA Form 483: Use Your CAPA Program to Stay Ahead of Auditors

Posted on Apr 7, 2023 9:00:00 AM

This year has seen a significant rise in Form 483s following FDA site visits. Plant management is getting caught off-guard when on-site auditors fixate on items that seemingly weren't in the scope of previous audits. If the FDA sees a product on hold for something out of range, they may ask if internal food safety investigations are in motion and if appropriate action is being taken. 

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Topics: Compliance, Audit, Food Safety, RCA

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