How to Appeal FDA Inspection Findings

digi — Thu, 05 Jun 2025 20:25:39 +0000

How to Appeal FDA Inspection Findings Navigating the Appeal Process for FDA Inspection Findings US FDA inspections are high-stakes events for pharmaceutical manufacturers, often resulting in observations documented on Form 483 or inspection classifications such as VAI (Voluntary Action Indicated) or OAI (Official Action Indicated). While most firms accept these findings and respond with Corrective...

FDA appeal guidance – Pharma GMP

How to Appeal FDA Inspection Findings