FDA Inspection
What is FDA Inspection?
An on-site evaluation by FDA investigators to assess compliance with FDA regulations at manufacturing, testing, or clinical trial facilities.
Why does FDA Inspection matter?
FDA inspections are unannounced (for domestic facilities) or pre-announced (international) visits where investigators examine operations, records, and facilities for regulatory compliance.
Inspections can be routine (every 2-3 years for drug manufacturers), for-cause (triggered by complaints, adverse events, or other signals), or pre-approval (before FDA approves a new drug manufactured at the facility).
Outcomes are classified as: NAI (No Action Indicated — clean), VAI (Voluntary Action Indicated — minor issues), or OAI (Official Action Indicated — serious problems requiring enforcement).
An OAI classification often leads to a Warning Letter or worse.
Related terms
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