Case Study: Pre-Approval (PAI) FDA Mock Audits in CAR-T and Viral Vector Manufacturing Sites

Case Study Overview

FDA inspection readiness is critical for cell and gene therapy manufacturers, where PAIs test both systems and team behavior. This case study shows how GMP Bridge ran PAI-style mock audits at two CGT sites (CAR-T and viral vectors), aligning teams with FDA expectations, identifying compliance gaps early, and building a clear remediation roadmap before the real inspection.

The Challenge

A global biotech company specializing in cell and gene therapies required independent FDA-style Mock Audits to evaluate the readiness of two advanced therapy manufacturing sites. With no recent FDA inspection experience, uncertainty about expectations, and teams unfamiliar with inspection dynamics, the company sought a trusted partner to provide a realistic PAI simulation and actionable feedback.

Quick Summary

Region: DACH (Germany, Austria, Switzerland)
Company Type: Global biotech company specializing in cell and gene therapies
Products: Autologous CAR-T therapies and viral vectors (clinical and commercial use)

Solution Delivered

Designed FDA-style Mock Audits for two manufacturing sites producing CAR-T therapies and viral vectors.
Prepared inspection agendas and document request lists aligned with FDA’s system-based approach.
Conducted multi-day on-site audits simulating FDA Pre-Approval Inspections (PAIs).
Audited Quality Systems, aseptic operations, sterility assurance, Environmental Monitoring, supplier qualification, and Quality Oversight.
Delivered comprehensive post-audit debriefs, highlighting leadership engagement and inspection behavior.
Issued a prioritized audit report with critical gaps and remediation actions.

Impact and Results

Leadership and teams gained firsthand exposure to FDA inspection dynamics and expectations.
Identified key compliance risks well ahead of scheduled FDA inspections.
Strengthened Quality Oversight and governance across both sites.
Provided a roadmap for remediation and risk reduction before FDA arrival.
Improved confidence and alignment between Quality and Manufacturing functions.

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