What FDA’s 2025 Enforcement Data Shows, and How Medical Device and IVD Manufacturers Should Prepare
By Dana Lagman and David Petrich
Key Findings from FDA 2025 Enforcement Data
A Landrich Insights review of FDA data shows 2025 inspection and enforcement rates at their highest level since pre-COVID. Inspection actions and warning letters rose significantly year-on-year. They overwhelmingly focused on breakdowns in process, documentation, and protocol maturity.
Although drugs and biologics comprise the majority of these actions, the Landrich Group believes now is the time for medical device manufacturers to prepare for increased scrutiny and ensure operational excellence. Given the proliferation of new devices and diagnostics in the public sphere, ranging from fitness wearables to minimal residual disease tests, there is every reason to believe the FDA will be attentive to the growing role devices and diagnostics play in the health care industry and society at large.
Our Analysis
The Landrich team reviewed a dataset from FDA’s FY2025 covering inspections and FDA warning letters. Inspection classifications of Official Action Indicated (OAI), which carry a recommendation for regulatory or administrative action, rose 22% from 315 to 383. FDA Warning Letters also rose 49%, from 225 to 336.
The FDA Form 483 and Warning Letter findings cover drugs, biologics, and devices, as noted earlier. FDA reports one classification for each project area within an inspection; therefore, a single inspection can generate more than one classification; the OAI count reflects classifications, not unique inspections. Drugs accounted for 77% of Warning Letters from FY2019 through FY2025, with a substantial portion related to unapproved GLP-1 compounds and gray-market peptides in the past two years.
The statistics are one more indicator of how inspection activity has recovered since the pandemic. Total inspections of drugs, biologics, and devices rose 11% in FY2025, to roughly 5,100, although that remains about 14% below FY2019. The growth was driven by domestic inspections, which rose 21% (from 3,094 to 3,734), while foreign inspections fell about 8% (from 1,487 to 1,369).
Key Patterns in Process, Operations and Documentation
In an era of innovative breakthroughs ranging from GLP-1 to precision medicine, technology is not the key reason for enforcement actions. Instead, the most common citations we reviewed point to more prosaic and avoidable failures of documented oversight.
Of the 73 FY2025 device-related OAI classifications with publicly posted citations, the most common themes were:
CAPA procedures: 44 classifications (60%)
Complaint handling: 40 classifications (55%)
Design validation and risk analysis: 27 classifications (37%)
The broader Form FDA 483 data follow a similar pattern, though CAPA and complaint handling were not as widespread. Among the 791 FDA Form 483s for FY2025 that we reviewed, the most commonly cited problems were:
CAPA procedures: (35%)
Complaint handling: (27%)
Purchasing controls: (14.5%)
Nonconforming product: (12%)
Process validation: (11.8%)
FDA’s public data does not include every inspection or citation, so these figures reflect publicly posted records.
Another striking aspect of our review of 2025 Warning Letters was the diversity of recipients. We identified 18 tied to clinical research, Bioresearch Monitoring (BIMO) oversight, or nonclinical Good Laboratory Practice (GLP) laboratories. These letters were addressed to clinical investigators, sponsors and sponsor-investigators, IRB oversight, and GLP laboratories. Eighteen letters do not indicate a widespread trend in clinical research. However, it was striking that enforcement attention spanned the entire network of collaborative stakeholders in the clinical research ecosystem, not merely sponsors.
The most frequently cited gaps for the classifications and actions were centered around CAPA, complaint handling, design validation and risk analysis, supplier (purchasing) controls, nonconforming product, and process validation.
Areas to Strengthen for Regulatory Resilience
In our reading, these point to four recurring weaknesses:
Problems detected but not investigated to root cause
Corrective actions not verified as effective
Third parties (e.g., suppliers, Contract Research Organizations (CROs), labs, sites) not demonstrably overseen
Procedures that exist but aren't followed, or aren't written
This analysis shows the value of focusing on a few high-priority areas where simple, practical activities can improve inspection readiness. Here are easy steps every IVD-related organization can take for regulatory resilience:
CAPA. Sample closed CAPAs across risk levels and reviewed overdue CAPAs. Try to think like an inspector and challenge the problem statements, root-cause logic, correction versus corrective action, verification and validation, and conduct effectiveness checks. Would an investigator see objective evidence that the root cause was thoroughly investigated, the actions addressed the issue, and that the implementation happened on schedule?
Complaints and Medical Device Reporting (MDR). Take the time to trace and trend complaints through intake, coding, investigation, risk assessment, MDR determination, closure, and trend review. Would an investigator see a uniform system for MDR investigation and triage, including linkage to CAPA, risk management, and field action when necessary?
Design and Risk. Create the meticulous mapping required for traceability of design inputs, analytical and clinical performance claims, validation, software changes, usability where relevant, cybersecurity, and risk controls. Would an investigator find traceability from hazard and intended use through requirements, verification or validation, residual-risk evaluation, labeling, and post-market signals? Would an investigator find that the Design History File (DHF) and the Risk Management File (RMF) have been updated throughout product lifecycles, as required?
Suppliers and Laboratories. Work with your procurement team to review your list of critical suppliers, contract manufacturers, software vendors, CROs, central laboratories, and specimen-service providers; test qualification, change notification, monitoring, and escalation. Would an investigator find documentation of risk-based controls proportional to criticality; current quality agreements; performance metrics; audit or assessment records; and documented action when performance deteriorates?
Clinical Oversight. Work with the clinical operations team to understand status of clinical processes and activities. This includes IRB/IEC approvals, monitoring reports, protocol deviations, informed consent forms, specimen handling, eligibility, endpoint adjudication, data queries, and vendor issues across sites. Would an investigator find documented protocols for qualification, delegation, monitoring, escalation, trend review, issue resolution, and verification that corrective actions were effective? Would an investigator find that the validity, integrity, and traceability of clinical study data are intact?
The Landrich Insights analysis of FDA inspection and enforcement data clarifies the underlying trend since COVID and illuminates the road ahead. We can expect the FDA to continue to increase resources and expect through scrutiny of process discipline and best practices in the medical device and diagnostic section. This is an opportunity for every organization to prepare and thrive in a regulatory climate that rewards internal controls for quality, compliance, and operational excellence.
Landrich Group helps Medical Device and IVD manufacturers and sponsors prepare for FDA inspections, from mock audits to remediation planning across quality systems, design history and risk management files, and clinical programs. If an inspection is on your horizon, a structured inspection readiness review now costs far less than a finding later. Learn more about our clinical quality and inspection readiness support at landrichgroup.com/services/clinical-services.
Sources: FDA Office of Inspections and Investigations (OII) Inspections Data Dashboard (inspections and classifications); FDA Inspection Observations (Form FDA 483 data); FDA OII Compliance Actions Dashboard (fiscal-year Warning Letter trends); FDA Warning Letters Database (2025 letters). Data accessed: October 2026. FDA updates these sources regularly, so figures may change. Fiscal year runs October 1 to September 30. A Warning Letter associated with more than one product type may appear under each applicable category. Analysis by Landrich Group.
