What to do before, during and after an FDA inspection

Always be prepared. The FDA has the authority to come in unannounced, as long as the facility is open for business. Be thoroughly familiar with the regulations, what you are required to do and what FDA can do.Decide who is the designated employee(s) to accompany the inspector.Be familiar with your company policies regarding what documents can be signed, what can be shown to an inspector, photography and document copying. Always be professional, honest, cooperative, respectful and calm, but also be on guard.Receive an FDA Form 482 - Notice of Inspection.Be aware that you should not be expected to interrupt production.If an investigator collects a sample, you should collect two duplicate samples and ask for an FDA Form 484 - Receipt of Samples.