FDA Intel

FDA inspection glossary

How FDA classifies inspections

After an inspection, FDA assigns a final classification (NAI, VAI or OAI) based on the inspection findings and the firm's response.

  • Timing. For human drug CGMP inspections, FDA aims to classify within 90 days of the inspection's end [2].
  • Letter to the firm. FDA sends the facility a letter with its classification [2].

On FDA Intel

each site page shows the final classification per inspection where FDA has issued one.

Sources

  1. fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-basics/inspection-classifications
  2. fda.gov/drugs/guidance-compliance-regulatory-information/pharmaceutical-inspections-and-compliance

See the term in real FDA documents. Your first Form 483 or letter is on us.

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