Think Like an FDA Inspector: Study the Manual
The best way to understand any FDA inspector's perspectives and what they're looking for when they enter your facility is to study inspections as they do, using FDA's official Investigations Operations Manual. Chapters 5, 7 and 8, on site inspections, recalls and investigations will be especially useful. But even Chapter 1, with official dos and don'ts will offer insights into why inspectors may react or interact with you as they do. A must read, courtesy of FDA's web site.
