What is an FDA Inspection?
The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm's compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act and related Acts.
After an inspection the is is either listed as No Action Indicated (NAI), Voluntary Action Indicted (VAI) or Official Action Indicated (OAI). NAI is the best outcome and OAI is the worst outcome. Continued issues can then further result in a warning letter or consent decree.
No Action Indicated (NAI)
An FDA inspection with NAI meands No actions indicated to the site after inspection.
Voluntary Action Indicated (VAI)
An FDA inspection with VAI means Voluntary actions indicated to the site after inspection.
Official Action Indicated (OAI)
An FDA inspection with OAI means Official action indicated by the FDA after inspection.
List of recent FDA Inspections and Outcomes since 2019Over 1,000 records