FDA Inspections and Enforcement in 2025: What Recent Trends Mean for Your Quality System
As FDA normalizes post-pandemic operations, its inspection posture is shifting. CDRH and ORA are refocusing on routine surveillance inspections while aggressively targeting high-risk facilities and quality system breakdowns. For small and mid-sized manufacturers, basic quality system robustness is back under the spotlight.
Recent enforcement trends highlight familiar themes that continue to trip up manufacturers: insufficient investigations (CAPA), disconnected complaint handling, incomplete design history files, and gaps in supplier management. However, 2025 brings new layers of complexity. FDA investigators are increasingly attentive to data integrity, cybersecurity for connected devices, and the readiness of firms to transition toward the Quality Management System Regulation (QMSR).
The "Project Mentality" is a specific vulnerability. Manufacturers that treat Quality as a periodic project—preparing for an audit only when notified—are struggling. FDA's risk-based inspection model leverages real-time data signals (MDRs, recalls, port-of-entry detentions) to target facilities. If your day-to-day operations don't match your documented procedures, the cracks will show immediately.
The Registration Connection
Crucially, inspection readiness starts before the investigator arrives. It starts with your regulatory footprint. FDA investigators often review your Establishment Registration and Device Listings before stepping foot in your building. If your listings show products you no longer make, or if your "Manufacturer" vs "Contract Manufacturer" roles are misaligned in FURLS, the inspection begins with skepticism.
Concrete Steps to Inspection Readiness
BRS LLC helps you connect your public regulatory data to your internal quality reality:
- Data Accuracy Audit: We review your FURLS account to ensure your device listings and site roles match your actual operations, removing "low hanging fruit" findings before an inspection.
- U.S. Agent Logistics: For foreign sites, we manage the critical inspection scheduling communications, ensuring you don't accidentally refuse an inspection due to missed emails.
- Complaint & MDR Triage: We assess your reporting logic to ensure adverse events are being escalated correctly, preventing "Failure to Report" citations.
- Gap Analysis: We provide targeted reviews of your high-risk subsystems (CAPA, Management Responsibility) to identify weaknesses before FDA does.
The practical question is not whether FDA will inspect, but how defensible your position will be when they do. Move from a reactive stance to a stable, inspection-ready posture.