FDA Inspection Readiness

FDA investigators are knocking at your door—are you ready? Your first thoughts may be of logistics— meeting space, document availability, the condition of your facility—but what about personnel? Are your employees prepared to face FDA investigators who are trained to thoroughly investigate a manufacturer’s entire operation?

The employees that know the most about your front-line operations are usually the ones who have the least experience with inspections and therefore are more likely to slip up. That’s why training of subject matter experts (SME) deserves at least as much attention in your inspection readiness plan as more tangible aspects like documentation and equipment function. Putting unprepared SMEs in the same room as trained FDA investigators who are there to interrogate and interview them is clearly not a good strategy. No matter how intelligent, well-educated and capable your people are, they can slip up and lead investigators through doors you might prefer to keep closed. FDA investigators can draw conclusions from what your SMEs say, what they don’t say, even the way they do or don’t say it. The best way to guarantee those conclusions reflect positively on your business is to prepare your staff for their moment in the spotlight and make sure they practice, practice, practice. This report offers guidance on developing an SME training plan, including selecting the best personnel to participate, assessing vulnerabilities and strengths, understanding common FDA interrogation techniques and testing readiness with simulated inspection interviews.