Pre-Approval Inspection (PAI)
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A Pre-Approval Inspection is an FDA on-site inspection of a manufacturing facility conducted in connection with a pending drug application — NDA, ANDA, or BLA — to verify that the data submitted are accurate and that the facility is capable of manufacturing the product in compliance with cGMP before FDA will approve the application.
PAIs are typically triggered by application review staff requesting field investigation, and they focus on data integrity — confirming that batch records, analytical data, and validation results submitted in the application match what actually happened at the facility — alongside a standard cGMP assessment of the specific manufacturing line and processes described in the application.
An OAI classification from a PAI can result in a Complete Response Letter even when the clinical and technical review of the application itself raised no concerns, because FDA will not approve an application it cannot verify was manufactured, or will be manufactured, in a compliant facility using accurate data.
- —Conducted in connection with a pending NDA, ANDA, or BLA, before approval
- —Verifies submitted data are accurate and the facility can make the product to cGMP
- —Distinct from routine surveillance inspections, which are not tied to a pending application
- —An OAI outcome can independently trigger a Complete Response Letter
FD&C Act §505; 21 CFR Part 211; FDA Compliance Program Guidance Manual 7346.832 (Pre-Approval Inspections)
Frequently asked questions
What is Pre-Approval Inspection (PAI)?
A Pre-Approval Inspection is an FDA on-site inspection of a manufacturing facility conducted in connection with a pending drug application — NDA, ANDA, or BLA — to verify that the data submitted are accurate and that the facility is capable of manufacturing the product in compliance with cGMP before FDA will approve the application.
Which regulations cover Pre-Approval Inspection (PAI)?
FD&C Act §505; 21 CFR Part 211; FDA Compliance Program Guidance Manual 7346.832 (Pre-Approval Inspections)