Essential Checklist for Preparing Your Facility for a US FDA Inspection

US FDA inspections are a pivotal part of regulatory oversight, determining a pharmaceutical facility’s compliance with Current Good Manufacturing Practices (cGMP) under 21 CFR Parts 210 and 211. Being prepared is not just about documentation—it’s about demonstrating control, traceability, and quality in every process. This article presents a practical, GMP-aligned FDA inspection preparation checklist designed to ensure your team is audit-ready at any time.

1. Pre-Inspection Readiness Strategy:

• Appoint an Inspection Coordinator and Response Team
• Establish a dedicated inspection room with printer, computer, and document access
• Define clear communication flow—who interacts with the inspector, who retrieves documents
• Assign Subject Matter Experts (SMEs) by department: QA, QC, Production, Warehouse, Engineering
• Perform a gap analysis using FDA Form 483 trends and Warning Letters

2. Documentation and Record Control:

• Ensure SOPs are current, version-controlled, and reviewed regularly
• Batch Manufacturing Records (BMRs) should be complete, reviewed, and archived
• CAPA, deviation, OOS, and complaint logs should be up-to-date with closure timelines
• All logbooks must be filled contemporaneously and free of overwriting or missing data
• Documentation must be attributable, legible, contemporaneous, original, and accurate (ALCOA+)

3. Quality Systems Review:

• Annual Product Quality Review (APQR) status and trend summaries
• Product recall procedures and mock recall reports
• Vendor qualification, audit reports, and supplier approval matrix
• Change control system effectiveness—ensure all changes are risk assessed and closed
• Management Review Meeting (MRM) minutes and quality indicators

4. Laboratory and Data Integrity Checks:

• Calibration, qualification, and maintenance records for all instruments
• Analytical method validation reports and stability data trending
• Audit trail review logs for electronic systems (21 CFR Part 11)
• OOS investigation reports and test repeat justifications
• Reference standard inventory, expiry checks, and CoAs

5. Facility Tour Readiness:

• Cleanliness, pest control, and hygiene standards across production, QC, and warehouse areas
• Ensure all manufacturing areas are labeled correctly and personnel adhere to gowning protocols
• Check HVAC validation, environmental monitoring, and pressure differentials
• Ensure materials and equipment are clearly identified as “Quarantined,” “Approved,” or “Rejected”
• Perform a visual walkthrough of process flows and line clearance compliance

6. Training and Personnel Preparedness:

• Training records should be current and role-specific
• Ensure team members know their responsibilities and how to present data or records confidently
• Mock interviews and inspection simulations for critical operators and analysts
• Refresher on GMP basics, data integrity, and inspection conduct

7. Material Management and Warehouse:

• Ensure receipt, sampling, quarantine, and release processes are SOP-compliant
• Check stock rotation (FEFO), temperature mapping, and raw material label integrity
• Maintain full traceability of raw material usage per batch
• Review returned goods, rejected goods, and destruction records

8. Equipment Qualification and Maintenance:

• Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) records
• Preventive Maintenance (PM) schedule adherence and breakdown logs
• Instrument calibration traceable to national or international standards
• Clean-in-Place (CIP) and sterilization cycle validation

9. Common Questions Inspectors May Ask:

• Can you show your last deviation investigation and its CAPA effectiveness?
• How often do you review audit trails for this HPLC system?
• Who approves your stability study protocols and how are samples pulled?
• Walk me through your product complaint handling process
• How do you ensure data integrity in electronic and manual systems?

10. Final Checklist for FDA Inspection Day:

1. Confirm all documentation is accessible and organized
2. Review the inspection communication plan
3. Ensure key personnel are on-site and briefed
4. Prepare for virtual inspection or remote regulatory assessment, if applicable
5. Maintain a calm, factual, and cooperative attitude during the inspection

Conclusion:

An FDA inspection can have far-reaching consequences, including approvals, warnings, or import alerts. With a proactive, well-structured inspection preparation checklist, pharmaceutical facilities can ensure they present their operations with confidence, transparency, and regulatory alignment. Inspection readiness is not a once-a-year activity—it’s an embedded component of GMP culture and continuous improvement.