GLOSSARYUS
Inspection Classification
The final result the FDA assigns to an inspected facility: NAI, VAI, or OAI. The FDA usually sends the classification to the firm in a letter within 45 to 90 days of the close of the inspection, depending on the inspection type.
Avoid This Mistake
A Form 483 is not the classification. A facility can receive a Form 483 and still be classified VAI.
Classifications
- No Action Indicated (NAI)Shows a facility is in an acceptable state of compliance. The facility usually did not receive a Form 483 at the end of the inspection.
- Voluntary Action Indicated (VAI)Objectionable conditions or practices were found, but the FDA decided the facility can correct them voluntarily and recommends no action. The facility usually received a Form 483.
- Official Action Indicated (OAI)Shows a facility is in an unacceptable state of compliance. The facility may have received a Form 483 at the end of the inspection.