FDA inspection glossary

Pre-approval inspection (PAI)

A pre-approval inspection is an FDA inspection of a manufacturing facility in support of a pending drug application, run under compliance program 7346.832.

Biologics. Pre-license and pre-approval inspections for biologics license applications follow compliance program 7346.832M [1].

Sources

FDA guidance document
fda.gov/drugs/guidance-compliance-regulatory-information/pharmaceutical-inspections-and-compliance

See the term in real FDA documents. Your first Form 483 or letter is on us.

Create a free account Search first