FDA inspection terminology – Pharma GMP

Understanding FDA’s NAI, VAI, OAI Ratings

digi — Wed, 04 Jun 2025 00:02:50 +0000

Understanding FDA’s NAI, VAI, OAI Ratings Understanding the Meaning and Impact of FDA’s NAI, VAI, and OAI Ratings After completing a GMP inspection, the US Food and Drug Administration (FDA) assigns a facility classification that reflects the severity of findings observed. These post-inspection ratings—No Action Indicated (NAI), Voluntary Action Indicated (VAI), and Official Action Indicated...

FDA Drug Manufacturing Facility Classification Outcomes (NAI, VAI, OAI)

digi — Tue, 03 Jun 2025 18:05:16 +0000

FDA Drug Manufacturing Facility Classification Outcomes (NAI, VAI, OAI) Decoding FDA Facility Classification Outcomes: NAI, VAI, and OAI Explained When the US Food and Drug Administration (FDA) inspects a drug manufacturing facility, the outcome of the inspection is not just reflected in a Form 483 or the Establishment Inspection Report (EIR)—it is also summarized in...