Search FDA Inspection Outcomes

Search FDA inspections and monitor FDA inspections and outcomes to surmize drug supply chain risk

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.

What is and FDA inspection with No Action Indicated (NAI)

An FDA inspection with NAI meands No actions indicated to the site after inspection.

What is and FDA inspection with Voluntary Action Indicated (VAI)

An FDA inspection with VAI means Voluntary actions indicated to the site after inspection.

What is and FDA inspection with Official Action Indicated (OAI)

An FDA inspection with OAI means Official action indicated by the FDA after inspection.

How should I use the FDA inspection list?

This is a good list to monitor for FDA inspection outcomes. Depending on the FDA inspection outcome you can use this in conjuction with other pharmaceutical competitive intelligence to surmize if there may be any drug shortage or drug supply impact due to the FDA inspection outcome. Too review FDA warning letters and 483s which may follow a poor FDA inspection see the following links.