How We Classify Inspections
Following an inspection, the agency evaluates the inspection findings to determines if the facility is in compliance with applicable laws and regulations and classifies the inspection.
The three classifications are:
- No action indicated (NAI), which means no objectionable conditions or practices were found during the inspection,
- Voluntary action indicated (VAI), which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action or
- Official action indicated (OAI), which means regulatory and/or administrative actions are recommended.
The agency maintains an inspection data dashboard that includes final inspection classifications (updated weekly) on FDA.gov. Once an inspection has been classified and it is considered closed it is added to this database.
However, not all inspections are included in the database. Those not included are:
- Inspections conducted by states, pre-approval inspections, mammography facility inspections, inspections waiting for a final enforcement action and inspections of nonclinical labs are not included.
- Inspections of nonclinical labs are available at non-clinical laboratories inspected under good laboratory practices.
The agency determines the final inspection classification by evaluating information collected during an inspection, as well as information provided by the facility following an inspection. Inspection classification recommendations from investigators are an important factor in the evaluation and in the classification process. Additional information is considered to determine the final inspection classification, including the facility’s response to inspectional observations highlighted in Form FDA 483 and the company’s proposed or completed corrective actions.