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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.
Next steps
Now is the time to ensure your facilities, equipment, and manufacturing processes are fully compliant with current regulations. For example, staff should be properly trained, complaint handling and adverse event reporting should be accurate and up-to-date, and facilities should be proactively swabbed to identify and remediate pathogens.
We offer our clients comprehensive preventative and reactive support, including:
- Contract review: We review supplier and customer contracts to identify potential risk areas and ensure that compliance obligations are clearly addressed.
- Policy and procedure evaluation: We evaluate and update existing policies and procedures to flag potential pitfalls that could arise during an inspection.
- Policy development: We draft missing or new policies and procedures to meet current regulatory expectations and strengthen compliance frameworks.
- Risk assessment guidance: We provide tailored guidance and walk-throughs to help clients assess risk areas, implement mitigation strategies, and prioritize corrective actions.
- Remediation guidance: We identify and prioritize areas that need remediation in order to reduce exposure and avoid enforcement actions before inspectors arrive.
- Form 483, untitled letter, and warning letter response support: We help companies implement corrective and preventive actions and craft comprehensive and timely responses to FDA enforcement documents to mitigate the risk of further enforcement actions.
With FDA inspections becoming more rigorous and data-driven, proactive preparation is critical – but reactive readiness is equally important. Reed Smith’s experienced team can help clients stay ahead of regulatory scrutiny, minimize risk, and respond effectively if issues arise. If you need assistance preparing for an inspection or responding to a Form 483 notice of observations, feel free to contact us. We are here to help you mitigate risk and protect your business.
Client Alert 2025-294
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