U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Inspection Basics
  4. Inspection classifications
  1. Inspection Basics

Inspection classifications

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: 

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. 

Back to Top