How to survive an FDA inspection! Part 2 Surviving an FDA Inspection Part 2 In Part 1 we discussed the key logistics involved with the FDA visiting your facility and the types of inspections they might wish to perform. Initial inspections, routine inspections and Quality System Surveillance Inspections are the most common. The FDA publishes […]

How to survive an FDA inspection! Part 1 It’s a Friday, late morning or early afternoon. You’re in the conference room with a few other executives of your medical device company. Also in the room is an inspector from the US Food and Drug Administration, the FDA. The inspector showed up the previous Monday for […]