Case Study 2. FDA Mock Audit

• Country: Germany
   
• Type of Company: Global biotech company specializing in cell and gene therapies
   
• Products: Autologous CAR-T therapies and viral vectors for clinical and commercial use
   

The client, a major biotech company, required independent FDA-style Mock Audits to assess the readiness of two manufacturing sites producing CAR-T therapies and viral vectors. Specific challenges included:

• No recent exposure to FDA inspections at site level
   
• Uncertainty regarding FDA expectations for advanced therapies (ATMPs)
   
• Leadership and teams unfamiliar with FDA inspection dynamics and questioning techniques
   
• Need for unbiased evaluation of compliance and inspection readiness across aseptic operations, Quality Systems, and sterility assurance
   

GMP Bridge conducted FDA-style Mock Audits at both sites, including:

• Pre-audit planning, document request list, and inspection agenda tailored to FDA’s system-based approach
   
• Onsite execution of multi-day Mock Audits simulating FDA Pre-Approval Inspections (PAI)
   
• Application of Socratic questioning to assess both systems and personnel behavior under inspection conditions
   
• Detailed inspection of Quality Systems, aseptic operations, sterility assurance programs, Environmental Monitoring, supplier qualification, and Quality Oversight
   
• Identification of gaps in FDA readiness, inspection management, and site governance
   
• Post-audit debriefs, including feedback on inspection behavior, leadership engagement, and risk communication
   
• Delivery of a detailed audit report prioritizing critical gaps and areas requiring immediate remediation
   

• Senior leadership and site teams gained firsthand experience in FDA inspection expectations and pressure scenarios
   
• Key compliance risks identified ahead of actual FDA inspections
   
• Strengthened Quality Oversight and inspection readiness across both sites
   
• Actionable roadmap provided to close identified gaps before FDA arrival
   
• Improved confidence and alignment across Quality and Manufacturing teams
   

Contact us to receive the detailed project report, including FDA Mock Audit structure, findings categories, and readiness improvement strategies.