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FDA inspection glossary

Official Action Indicated (OAI)

OAI means regulatory and/or administrative actions are recommended. The facility is in an unacceptable state of compliance.

  • Possible consequences. For drug facilities, FDA may withhold approval of pending applications that list the facility, as well as export certificates [3].
  • Changing it. FDA generally changes an OAI classification only after verifying corrective actions through an onsite follow-up inspection [3].

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
  3. 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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