FDA Chapter 46: Compliance Program 7346.832: Pre-Approval Inspections/Investigations
Title:
FDA Chapter 46: Compliance Program 7346.832: Pre-Approval Inspections/Investigations
Short Title:
PAI-Inspections
Origin/Publisher:
FDA
Document Type:
Compliance Program Guidance Manual
Content:
A pre-approval inspection (PAI) is performed to contribute to FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.