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# FDA Warning Letters Surge in FY2025, Report Finds
- URL: https://www.fdaweb.com/fda-warning-letters-surge-in-fy2025-report-finds/
- Published: 2026-03-13T12:00:00.000Z
- Updated: 2026-09-14T13:35:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160813

FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, issuing 303 Warning Letters to companies involved with drugs and biologics — up 59% from 190 letters in FY2024 — according to a new analysis from consulting firm Eliquent Life Sciences. The report, authored by regulatory experts **Erin Hartmann** and **Liz Oestreich**, attributes the jump largely to a surge in unapproved drugs entering the market, particularly compounded versions of high-demand weight-loss therapies and products sold through telehealth platforms.

Of the 303 warning letters issued in FY 2025, 167 were not tied to on-site inspections. Instead, they stemmed from regulatory reviews of Web sites, product labeling, promotional materials, and remote document requests, the report finds. Online telehealth platforms were a major focus. FDA issued 58 Warning Letters to Web sites selling compounded drugs, many tied to demand for weight-loss products in the class of glucagon-like peptide-1 (GLP-1) therapies.

The agency continues to rely on remote regulatory tools. In FY2025, it issued 22 Warning Letters following requests for records under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. Most of those letters involved foreign manufacturers, including 13 in China and three in India. Nearly all resulted in companies being placed on import alert, effectively blocking their products from entering the U.S. market. Analysts said the pattern suggests regulators are increasingly using remote document requests as a resource-efficient way to monitor international facilities.

FDA also intensified oversight of drug marketing practices. Eleven Warning Letters were issued after reviewing promotional materials, primarily for prescription products. Most cited advertising that highlighted efficacy while downplaying safety risks, creating what regulators described as misleading impressions about the products’ benefit-risk profiles. Eight of the cited companies also failed to submit the materials to the agency when they were first distributed, as required. The enforcement activity aligns with the FDA’s announcement in September 2025 that it would step up efforts against deceptive drug advertising.

FDA issued 135 warning letters following inspections in FY2025, continuing a multi-year rise in inspection-based enforcement. Over-the-counter products accounted for the largest share, with 61 letters involving products such as topical analgesics, hand sanitizers and sunscreens. Domestic firms received the majority of inspection-related letters, accounting for roughly 63% of cases, while the remainder were issued to companies in 13 other countries.

Despite the increase in enforcement activity, the types of violations cited in warning letters remained largely consistent with previous years, according to the report authors. Among the most common findings were failures involving quality oversight, manufacturing process validation and ingredient testing under current good manufacturing practice regulations. The most frequently cited provisions included requirements for quality control units, written production procedures, and identity testing of drug components. FDA inspectors also cited companies for inadequate investigations of manufacturing deviations and insufficient stability testing programs.

The analysis suggests internal restructuring may be helping FDA issue Warning Letters more quickly. In 2024, the agency reorganized its field operations into the Office of Inspections and Investigations, consolidating compliance functions within product-specific centers. According to agency officials cited in the report, the change has shortened the time required to issue warning letters following inspections. Despite staffing reductions in 4/2025, enforcement levels remained strong, the authors say, although the long-term effects of the workforce cuts may become clearer in FY2026.