This month, April 2026, the Center for Drugs Evaluation and Research’s (CDER’s) Office of Compliance (OC) issued its yearly report, highlighting many of its goals, new programs, and accomplishments.  First, let’s take a look at the report by the numbers.

According to the report (here), the OC lists the following workload figures:

Office of Compliance actions:

  • 314 warning letters issued
  • 321 drug recall events classified, totaling 755 recalled products
  • 10,922 drug listings inactivated from the FDA’s Drug Registration and Listing System
  • 85 regulatory meetings held with companies

Office of Compliance reviews:

  • 970 drug manufacturing inspection classification letters issued
  • 42 Preliminary Notices of Noncompliance issued for potential ClinicalTrials.gov violations
  • 100 percent of clinical inspection summaries issued by agreed upon goal dates for new drug applications and biologics license applications under the Prescription Drug User Fee Amendments (PDUFA) and Biosimilar User Fee Amendments (BsUFA)
  • 8,700+ electronic certificates of pharmaceutical product issued to provide documentation of facilities’ compliance with FDA standards
  • 409 inspection and compliance documents shared with foreign regulatory counterparts

Office of Compliance engagements:

  • 12 policy documents issued or contributed to
  • 7,000+ drug registration and listing inquiries processed
  • 5,142 self-guided compounding training courses completed by 2,449 participants;
    16 instructor-led course sessions held with 169 participants
  • 35 public notifications posted to the web about hidden drug ingredients
  • 60+ presentations given before external audiences

The OC also spent considerable resources addressing concerns about unapproved, misbranded, and/or counterfeit unsafe GLP-1 drugs and compounding that fell outside of regulatory acceptability.  One key action was the establishment of a “worldwide ‘green list’ import alert to help stop poor quality and potentially dangerous GLP-1 active pharmaceutical ingredient (API) from unverified foreign sources entering the U.S. market.”  The list includes APIs from facilities the Agency has inspected or evaluated that appear to be in compliance with the FDA’s rigorous standards – standards applicable to all APIs manufactured in the U.S.  APIs from other sources are subject to detention without physical examination.

CDER’s OC worked to combat the sale of illegal drugs online and we have acknowledged its efforts in numerous previous blog posts.

Another initiative for which we’ve seen recent action involves notification to firms for their failure to list required clinical trials on Clinicaltrials.gov.  The FDA states that, based on its notifications, “[n]early 90 percent of these parties have since successfully posted their required clinical trial information to ClinicalTrials.gov.”

The OC’s oversight of the Drug Supply Chain Security Act is now front and center as there has been at least one warning letter issued in 2025 for failure to comply with the Act’s requirements.  We’ll likely see additional enforcement action regarding this issue during the remainder of 2026.

The Agency works to protect consumers and has issued numerous warning letters, alerts, and safety notifications for various categories of products, including fat-dissolving injections, unapproved ophthalmic products, unapproved bodybuilding products, health and dietary products containing dangerous hidden drug ingredients, and ingestible unapproved fluoride products, as well as additional categories of enforcement actions as noted in the report.

The Agency keeps busy, and there is no shortage of work chasing those who intend to place our public in harm’s way by introducing dangerous, illegal, and unsafe products to U.S. commerce.  It would be worthwhile to read the entire report (at the link found in the beginning of this post) to better familiarize yourself with the scope of work of CDER’s Office of Compliance and how its work helps shield “the public from poor-quality, unsafe, and ineffective drugs through proactive compliance strategies and risk-based enforcement actions.”