Close-Out Meetings With FDA Investigators: What Manufacturers Need To Know Before Their Next Inspection
A Compliance 360° Q&A
Executive Summary
When the US agency comes to inspect a manufacturer’s facility, one of the more important activities that occur is a close-out meeting. Consultant and former FDA investigations branch director Ricki Chase explains why these meetings, held daily or at the end of an audit – or both – can help make or break an inspection.