How Do You Prepare for an FDA Inspection at Your Supplement Facility?
The key to a successful FDA inspection is preparation, not panic. Keep your GMP records current and organized, assign clear roles for who handles the inspector, and run mock inspections so your team already knows what to expect.
What Records Should You Have Ready Before an FDA Inspector Arrives?
Your records must be organized, accurate, and readily available. Assign clear roles ahead of time so everyone knows who greets the inspector, who gathers documents, and who is authorized to answer FDA questions.
Why Do Mock Inspections Help With FDA Inspection Readiness?
Mock inspections train your team on inspection behavior so they aren’t caught off guard. During an actual inspection, honesty and cooperation with the FDA go a long way — preparation reduces risk and builds credibility.
Video Transcript
Today we’re talking about how to prepare for an FDA inspection. The first rule is simple: don’t panic — have a plan.
Inspection readiness starts with clear roles. You should know who greets the inspector, who gathers documents, and who is authorized to answer FDA questions.
Your records must be organized, accurate, and readily available, and your team should be trained on inspection behavior. Mock inspections are one of the best ways to avoid being caught off guard.
During an inspection, honesty and cooperation go a long way with the FDA. Preparation reduces risk and builds credibility. If you need help getting inspection-ready, we’re here for you.
Frequently Asked Questions
What is the first step in preparing for an FDA inspection?
Assign clear roles ahead of time — know who will greet the inspector, who will gather documents, and who is authorized to speak on the company’s behalf.
What records does the FDA expect to see during an inspection?
Current, accurate GMP records that are organized and can be pulled on demand, not assembled after the fact.
Are mock inspections worth the time?
Yes — they train staff on how to interact with an inspector and reduce the chance of being caught off guard during the real thing.
What happens if my facility isn’t inspection-ready?
Disorganized records or untrained staff can turn a routine inspection into a Form 483 or warning letter. Preparation is the best way to avoid that outcome.
This video and transcript are provided for general educational purposes only and do not constitute legal advice. For guidance specific to your facility, contact us today.