As 2025 progresses, the U.S. Food and Drug Administration (FDA) has markedly intensified its inspection and enforcement activities. Reed Smith has observed that clients in the food, drug, device, and cosmetic industries have experienced a notable increase in the number of FDA inspections this year. These inspections are characterized by greater frequency, heightened scrutiny, larger inspection teams, more swabbing of facilities for pathogens, and longer inspection durations compared to previous years.

Increased frequency of enforcement activity

After a brief pause in enforcement activity at the start of 2025, the FDA has greatly accelerated its issuance of warning letters. Between July 1, 2025 and December 3, 2025, the Agency issued 327 warning letters, a 73% increase over the same period in the prior year. This uptick reflects both internal realignment and external pressures to demonstrate regulatory vigilance amid increased public and congressional scrutiny.

The agency’s heightened enforcement posture is underscored by a sharp increase in untitled letters, which, though they are less severe than warning letters, serve as formal notice addressing violations of the Federal Food, Drug, and Cosmetic Act (FDCA), including adulteration, misbranding, and other objectionable conditions. In fiscal year 2025, the FDA issued 58 untitled letters – —up dramatically from just five in 2024 and four in 2023 – —signaling a notable escalation in regulatory scrutiny.

This trend extends beyond correspondence. In fiscal year 2025, the FDA conducted 694 more inspections compared to fiscal year 2024. Taken together, these developments signal a clear shift toward more oversight, with the FDA leveraging both correspondence and on-site inspections to reinforce compliance expectations across the industry.

AI-driven inspection targeting

The June 2025 launch of the FDA’s internal AI system, “Elsa,” has introduced a new level of analytical precision. Elsa analyzes internal FDA data – including adverse event reports, anomalies in compliance data, Form 483 observations, and historical inspection outcomes – to prioritize high-risk facilities for inspection. Facilities with unresolved inconsistencies or corrective and preventive actions (CAPAs) may be flagged earlier and more frequently, resulting in more focused enforcement.

Foreign manufacturers face heightened oversight

In line with recent policy shifts, the FDA announced in a May 6, 2025, press release that it has expanded its use of unannounced inspections at foreign manufacturing facilities, facilities, particularly in countries such as China and India, which supply a sizable portion of active pharmaceutical ingredients for the U.S. market. This move aims to eliminate the double standard between domestic and foreign manufacturers and to expose noncompliance that might otherwise be concealed during preannounced inspections. The FDA has underscored its authority to take regulatory action – including import alerts and criminal penalties– against companies that attempt to delay, deny, or limit inspections.