FDA Compliance Office Ramped Up Enforcement in 2025

FDA sharply expanded enforcement and oversight activities in 2025, issuing hundreds of Warning Letters and targeting a wave of unapproved and counterfeit drugs — particularly popular weight-loss medications — according to a just-released annual report from CDER’s Office of Compliance. The report outlines a year marked by increased regulatory activity, rising risks tied to online drug sales, and intensified scrutiny of global supply chains.

CDER says it issued 314 Warning Letters in 2025, a significant increase driven largely by violations involving unapproved or misbranded drugs and manufacturing quality failures. More than 180 letters cited illegal or misleading drug marketing, while over 120 targeted manufacturing facilities for deviations from current good manufacturing practices.

The agency also classified 321 drug recall events involving 755 products and inactivated more than 10,900 drug listings from its registration system.

“[We] strengthened our oversight to better shield Americans from poor-quality, unsafe, and ineffective drugs,” says CDER Office of Compliance director Jill P. Furman in the report.

A major focus in 2025 was the explosion in demand for glucagon-like peptide-1 drugs such as semaglutide and tirzepatide, which has fueled a parallel market of unapproved and counterfeit versions. CDER says it deployed a “multi-faceted strategy” to combat the trend, including issuing Warning Letters to companies marketing copycat products and establishing a global “green list” import alert to block potentially unsafe active pharmaceutical ingredients from unverified foreign sources.

The report highlights growing concerns about illegal online drug sales, with FDA stepping up enforcement against telehealth firms, rogue pharmacies, and websites selling unapproved products.

The Office of Compliance also intensified its oversight of clinical research and manufacturing It reviewed more than 590 inspections of clinical investigators, sponsors, and institutional review boards, and evaluated over 1,000 complaints related to trial conduct, according to the report. The agency issued 14 warning letters tied to clinical research violations and produced 141 clinical inspection summaries to support drug approval decisions.

On the manufacturing side, regulators issued 970 inspection classification letters and continued monitoring compliance across domestic and foreign facilities.

Ensuring the integrity of the drug supply chain remained a central priority, CDER say, particularly under the Drug Supply Chain Security Act. FDA conducted dozens of inspections and compliance actions to prevent counterfeit or substandard drugs from entering the U.S. market. The agency also made 250 adjustments to import alerts and reviewed hundreds of import requests for drugs nearing approval.

Globally, FDA shared more than 400 inspection and compliance documents with foreign regulators and participated in international efforts to combat falsified medicines.

Beyond enforcement, FDA emphasizes early intervention and industry outreach. The agency sent thousands of notifications to companies about compliance requirements, helping correct more than 5,000 drug listing issues before escalating enforcement.

Officials say they are also increasingly using tools such as artificial intelligence and risk-based monitoring to anticipate emerging threats.