The U.S. Food and Drug Administration (FDA) issued 303 warning letters to drug and biologics manufacturers in FY2025, a 59% increase from 190 the year before., and the rate has held steady into 2026. This increase, coupled with evolving inspection practices, underscores the importance of proactive regulatory compliance for FDA-regulated companies. Across drugs, medical devices, biologics, and food, recent inspections and warning letters point to three areas of focus. For manufacturers, sponsors, and other regulated businesses, understanding these enforcement trends is critical to identifying compliance gaps, preparing for inspections, and reducing the risk of regulatory action.
1. FDA Expands Unannounced Inspections of Foreign Manufacturing Facilities
The FDA is expanding unannounced inspections at foreign facilities that manufacture food, drugs, and medical products for the U.S. market, building on a pilot program in India and China. The agency conducts about 12,000 domestic and 3,000 foreign inspections each year. According to the FDA, inspectors have identified serious deficiencies at foreign sites more than twice as often as at domestic facilities, despite foreign facilities historically receiving advance notice of inspections. The FDA can take regulatory action against any firm that delays, denies, or limits an inspection, and the House FY2027 appropriations report calls for more unannounced overseas inspections.
What regulated companies should do:
Companies should maintain inspection readiness across their manufacturing operations, including contract manufacturers and overseas suppliers. Sponsors and manufacturers retain applicable regulatory responsibilities for activities outsourced to contract development and manufacturing organizations (CDMOs). Companies should review supplier qualification procedures, quality agreements, audit schedules, and inspection readiness protocols to identify and address potential gaps before an FDA inspection occurs.
2. Quality System Deficiencies, Data Integrity, and CAPA Remain Key FDA Enforcement Priorities
Weak quality systems and data integrity failures remain recurring issues identified in FDA inspections and warning letters. A frequent issue is inadequate corrective and preventive action (CAPA), particularly when corrective measures fail to address the underlying root cause of a deficiency. Inadequate remediation can also expose companies to additional regulatory scrutiny, including subsequent warning letters when previously identified violations remain unresolved.. Data integrity concerns appeared in about 15% of FY2025 warning letters overall, with about 60% of those being sent to Indian sites. The FDA also issued its first warning letter addressing the inappropriate use of artificial intelligence (AI) to generate current Good Manufacturing Practice (CGMP) documentation without adequate review by qualified personnel. The action highlights the importance of maintaining appropriate human oversight when using AI tools in regulated manufacturing operations.
What regulated companies should do:
Companies should verify the effectiveness of corrective and preventive actions before formally closing CAPA investigations. They should also assess audit trails, data access controls, deletion permissions, and backup procedures to ensure the integrity and reliability of regulated records. Where AI tools are used to develop standard operating procedures (SOPs), batch records, or investigation reports, companies should establish appropriate controls requiring review and approval by qualified, authorized personnel before those documents are implemented or relied upon for CGMP compliance.
3. FDA’s Risk-Based Inspection Strategy Increases the Importance of Compliance Data
The FDA uses a risk-based approach to prioritize inspections, considering factors such as product risk, compliance history, recalls, and time since the last inspection. The agency is also expanding its use of data and technology to support regulatory oversight and inspection planning. For food companies, importer records under the Foreign Supplier Verification Program (FSVP) provide the FDA with information about foreign suppliers without requiring a site visit. Import alerts may also be implemented before a public warning letter is issued. Since April 2026, the FDA has been piloting one-day inspectional assessments to supplement its traditional inspection program and conduct more targeted evaluations of regulated facilities.
What regulated companies should do:
Companies should regularly evaluate their compliance history, including product recalls, customer complaints, prior FDA Form 483 inspectional observations, and applicable importer records. Maintaining accurate documentation, addressing previous inspection findings with evidence of effective corrective actions, and monitoring FDA import alerts involving products and suppliers can help companies identify potential regulatory risks and strengthen their inspection readiness.
Preparing for Increased FDA Inspection and Enforcement Scrutiny
The FDA’s evolving inspection practices reinforce the importance of maintaining effective quality systems, reliable compliance documentation, and ongoing regulatory oversight. As the agency expands unannounced inspections, continues to scrutinize recurring compliance deficiencies, and adopts more targeted inspection approaches, regulated companies should evaluate their existing compliance programs and address potential vulnerabilities before they result in enforcement action.
A proactive, year-round approach to inspection readiness can help companies reduce regulatory exposure, minimize operational disruptions, and respond more effectively to FDA inspections and enforcement inquiries.
How Frier Levitt Can Help
Frier Levitt advises FDA-regulated companies on regulatory compliance, inspection readiness, quality system requirements, and enforcement matters. Our attorneys work with manufacturers, sponsors, and other regulated businesses to assess compliance risks, address FDA inspection findings, and develop strategies for responding to regulatory scrutiny involving domestic and foreign operations. Contact Frier Levitt to discuss how we can help your organization strengthen its compliance program and prepare for FDA inspections.
Partner, Chair of the FDA Practice
