FDA Inspect facilities or establishments which manufacture, process or market FDA regulated products like Medical device, drug, food, and cosmetics. Most of the time FDA select facility for inspection randomly. FDA Inspection facilities to make sure, it is complying with GMP regulations. For food facility FDA inspects against the 21 CFR 110 and for dietary supplement it is 21 CFR 111. If you are a medical device establishment the corresponding GMP section is 21 CFR 820 and for drug establishments, it is 21 CFR 210 and 211.
You must have the quality manual, quality policy, quality system procedures and SOP’s ready available during the audit. FDA will inspect all documents to verify the accuracy especially CAPA documents, non-confirming products, customer complaints, Medical device reporting procedure etc.
After FDA Inspection if any variations from GMP found, the auditor will explain this at the closing meeting and issue FDA 483 form which are FDA observations. You have 15 days’ time to respond to it.
If you need assistance with FDA pre-inspection, GAP analysis, GMP implementation or FDA 483 response, LMG Can help you.