FDA classifies inspections based on a company’s state of compliance as acceptable or unacceptable with respect to CGMP requirements:

• No action indicated (NAI) classification indicates a facility is in an acceptable state of compliance. The facility, usually, was not issued a Form FDA 483 at the conclusion of the inspection.
• Voluntary action indicated (VAI) classification indicates the inspection found objectionable conditions or practices but the agency has determined the facility can voluntarily correct its deficiencies and will not recommend any action. Usually, the facility was issued a Form FDA 483 at the conclusion of the inspection.
• Official action indicated (OAI) classification indicates a facility is in an unacceptable state of compliance.

FDA strives to complete its CGMP classification of human drug facility inspections within 90 days of the end of the inspection. The agency sends the facility a letter with the classification (examples: NAI, VAI and OAI letters) and generally posts the classification to the data dashboard.

The facility-specific data dashboard contains information on surveillance and for-cause inspections for drugs, biologics and other medical products dating back to 2009, as well as data on a facility’s inspection history, including warning letters.

Additionally, for facilities with an OAI-classified CGMP inspections, FDA may withhold:

• approval of any pending drug applications that list the facility
• export certificates for drugs intended for distribution outside of the U.S.
• CGMP declarations for drugs intended for distribution outside of the U.S.

Government purchasing contracts may also be adversely impacted by an OAI classified inspection.

Generally, FDA will only change an OAI inspection classification after a company implements comprehensive corrective and preventive actions that are verified through an onsite follow-up FDA inspection.