Increased frequency of enforcement activity

Following a brief pause in enforcement at the start of 2025, the FDA significantly accelerated its issuance of warning letters. Between July 1 and December 3, 2025, the agency issued 327 warning letters, representing a 73% increase over the same period in 2024. This uptick reflects both internal realignment and external pressures to demonstrate regulatory vigilance amid heightened public and congressional scrutiny.

The agency’s enforcement posture is further underscored by a sharp increase in untitled letters, which—though less severe than warning letters—serve as formal notices 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 written enforcement. In fiscal year 2025, the FDA conducted 694 more inspections compared to fiscal year 2024. Taken together, these developments demonstrate a shift toward more oversight, with the FDA leveraging both correspondence and on-site inspections to reinforce compliance expectations across the industry.

Enforcement and inspection trends by product type

A review of FDA data reveals notable changes in enforcement activity and inspections across product categories. According to the FDA Compliance Dashboard, when comparing the numbers from fiscal years 2024 and 2025, the breakdown of warning letters and inspection data by product type is as follows:

Warning Letters by Product Type:

Product type	FY 2024	FY 2025
Biologics	15	26
Devices	42	45
Drugs	167	249
Food/Cosmetics1	148	93

Inspections by Product Type:

Product type	FY 2024	FY 2025
Biologics	1.49k	1.42k
Devices	2.15k	2.33k
Drugs	1.93k	1.9k
Food/Cosmetics	10.22k	11.76k

 

This data reflects a shift in enforcement and inspection activity between fiscal years. Enforcement activity increased across biologics, devices, and drug industries, as reflected by higher warning letter counts, with the drug industry experiencing the most significant spike. The drug industry recorded 82 more warning letters compared to the prior year. This surge is largely attributable to a concentrated enforcement action on September 9, 2025, when the FDA launched a crackdown on deceptive drug advertising. On that day alone, the agency issued over 60 warning letters. The food and cosmetics industries recorded a significant increase of 1,540 inspections from 2024 to 2025, while the device industry experienced an uptick in both warning letters and inspections. Overall, all four industries experienced heightened FDA oversight in 2025, whether through increased warning letters, expanded inspection activity, or both.

AI-driven inspection targeting

The June 2025 launch of the FDA’s internal AI system, “Elsa,”  introduced a new array of analytical tools and possibilities in FDA’s arsenal. 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.

According to FDA, predictive analytics means inspections are increasingly risk-based rather than random, reducing the likelihood of surprise visits for low-risk facilities while intensifying scrutiny for those flagged by data anomalies. Companies should anticipate less leniency and more precision in enforcement actions as machine learning models evolve.

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, particularly in countries such as China and India, which supply a sizable portion of active pharmaceutical ingredients for the U.S. market. This initiative 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.

With foreign facilities producing a significant share of active pharmaceutical ingredients, unannounced inspections aim to close compliance gaps that have historically led to recalls and import alerts.

Next steps

Now is the time to prepare for heightened FDA scrutiny and ensure your operations are fully compliant with evolving regulations. This includes ensuring staff is properly trained, maintaining accurate and up-to-date complaint handling and adverse event reporting systems, and proactively monitoring facilities to identify and remediate pathogens before they trigger enforcement actions.

We offer our clients comprehensive preventative and reactive support, including:

• Contract Review: Reviewing supplier and customer agreements to mitigate vulnerabilities and ensure compliance obligations are met. This may include requiring supplier documentation and conducting periodic audits of third-party facilities.
• Training and inspection readiness: Strengthening training programs to ensure staff is inspection-ready and meeting regulatory requirements. This may include conducting mock inspections and refresher courses to prepare teams for real-world scenarios.
• Verifying reporting accuracy: Reviewing complaint handling and adverse event reporting systems to ensure they are current, accurate, and FDA compliant. This includes auditing electronic reporting systems to ensure timely submissions and eliminating discrepancies in adverse event logs.
• Proactive environmental monitoring: Implementing systems for routine swabbing and pathogen testing in high-risk areas to remediate pathogens before they trigger enforcement concerns. For instance, routinely testing Listeria and Salmonella in production lines and storage facilities.
• Compliance framework review: Evaluating policies, Standard Operating Procedures (SOPs), and quality systems to ensure they align with FDA guidance and identifying areas for improvement.
• Policy development: Drafting new policies to address gaps or meet evolving regulatory expectations, including clear safety procedures and timelines for corrective actions.
• Risk assessment guidance: Providing tailored guidance to help clients conduct comprehensive risk assessments, identify vulnerabilities in processes, equipment, and documentation, and prioritize corrective actions before they lead to non-compliance.
• Remediation guidance: Assisting in implementing corrective measures for issues identified during risk assessments, such as replacing outdated equipment, improving sanitation protocols, or enhancing data integrity.
• Enforcement response planning: Developing internal protocols and playbooks for timely and comprehensive responses to Form 483 observations, CAPAs, untitled letters, and warning letters. This includes developing templates for FDA correspondence and assigning responsibility for corrective 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.
1. These product categories are combined by FDA on its Dashboard.