2020 - FDA: Mock and Pre-Approval Inspections (PAIs) - Part II

Purpose of Inspections and a Mock Audit
Strategy for Mock Audits
Dos and Don’t
Background
Pre-Approval Inspection Compliance Program 7346.832
Findings and Deficiencies to Withhold Approval of an Application
Domestic/International PAIs and Types of PAIs
Priority Pre-Approval Inspections
Overall Overview of the Three Primary Inspectional Objectives Regarding the PAI Program
Priority Pre-Approval Inspection- FDA Recommendations and Reasons for Not Conducting this Type of PAI
Reasons for Conducting a Discretionary Pre-Approval Inspection and Investigator Preparation before a PAI
PAI-Type and Depth of Inspection/Audit Coverage, Objectives, and Techniques
PAI Inspection Reporting
PAI Inspection Reporting and Sample Collection or Sample Submission Requests
FDA Laboratory Analysis of Samples
Findings That May Result in an FDA-483
Impact of a Negative PAI Report