Preapproval Inspections and Audits


Understanding How Pre-approval Inspections are Scheduled

A PAI should be performed at the earliest opportunity in order to meet the district goal date. It may be combined with other programs or for-cause inspections as necessary for efficient and effective inspection coverage. Read More

The Focus of the Pre-Approval Inspection

A preapproval 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. Read More

Who is on the FDA Inspection Team

Preapproval inspections (PAI) should be, whenever possible, a team approach with at least one investigator and one analyst. Districts are to assign experienced investigators and analysts to perform PAIs. Investigators and analysts conducting these inspections will be qualified by appropriate training and experience. Read More