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.
SafetyChain Blog
Avoid FDA Form 483: Use Your CAPA Program to Stay Ahead of Auditors
Posted on Apr 7, 2023 9:00:00 AM
Topics: Compliance, Audit, Food Safety, RCA