CDER Warning Letters Jump 50% in FY 2025 — What That Means for Industry
FDA enforcement is accelerating. The latest data shows where the agency is focusing and what companies should be preparing for now.
The following explainer synthesizes reporting from Joanne S. Eglovitch at RAPS.
According to a recent article from Regulatory Affairs Professionals Society (RAPS), an official at the FDA confirmed that warning letters issued by the Center for Drug Evaluation and Research (CDER) rose by a whopping 50% in fiscal year 2025 — a sharp signal that regulators are intensifying scrutiny across multiple fronts.
The revelation came from Jill Furman, director of CDER’s Office of Compliance, during the 2025 Enforcement, Litigation, and Compliance Conference, where she addressed enforcement trends and compliance priorities.
The drivers of the warning letters
Furman provided a breakdown of the principal factors behind the increase, per the RAPS report:
Roughly 22% of warning letters targeted telehealth platforms marketing compounded drug products with false or misleading claims, including companies promoting compounded versions of GLP-1 (glucagon-like peptide-1) diabetes or weight-loss drugs.
About 35% were related to drug manufacturing facilities that failed to meet GMP standards.
18% involved unapproved drugs or misbranding violations.
A smaller share — 5% — concerned non-compliance in clinical research or Institutional Review Board (IRB) oversight.
Furman described FY 2025 as “a year of change” for her office. The former Office of Regulatory Affairs was reorganized into the Office of Inspections and Investigations (OII), a reorganization she said enhanced coordination across sub-offices and strengthened enforcement capacity.
Import alerts, new “Green List” and supply-chain crackdowns
Enforcement in FY 2025 extended beyond domestic oversight. RAPS reports that the FDA issued 126 import alerts (a significant uptick compared with prior years).
Notably, this comes as the FDA introduced a so-called “Green List” in September 2025: a mechanism aimed at preventing potentially unsafe active pharmaceutical ingredients (APIs) from unverified foreign sources, particularly those for GLP-1 drugs, from entering the U.S. supply chain. APIs from foreign manufacturers not on the Green List may be subject to detention without physical inspection.
Baker & Hostetler LLP has a great introductory and analysis piece on the green list if you need the background.
The broader enforcement focus: “Botox-type” products, ophthalmics, clinical trials, recalls
The RAPS article also highlights other key enforcement priorities for CDER in 2025:
The agency issued 18 warning letters to firms marketing fraudulent or unapproved “Botox-type” products, warning that such products pose serious safety risks, including potential counterfeiting, incorrect/inactive ingredients, or falsification.
There was increased scrutiny on ophthalmic (eye-related) products and other high-risk drug categories, as part of a broader push to curb the distribution of dangerous or misbranded products.
On the clinical research side: CDER reviewed clinical data submissions for more than 150 marketing applications, investigated over 900 complaints related to bioresearch violations, and issued 21 official action indicated (OAI) / Form 483 findings, including instances where companies failed to submit required investigational new drug (IND) applications.
And on product safety: FY 2025 saw 317 drug-recall events, most classified as Class II (moderate risk but still serious), per the RAPS report.
Why this matters and what to watch
A few thoughts here:
The regulatory risk is rising—not shrinking. A 50% jump in warning letters signals that CDER’s compliance teams are more active and more aggressive than in prior years. Companies in compounding, telehealth, manufacturing, or international supply chains should expect intensified scrutiny. Especially given Bloomberg’s recent reporting that the FDA is gearing up for a hiring spree.
Third-party supply chain control is tightening. The introduction of the Green List and increased import alerts mark a shift toward more rigorous gatekeeping at U.S. borders. Foreign API producers must demonstrate full compliance with FDA standards, creating a growing choke point for companies relying on overseas ingredients.
Special focus on GLP-1 products. Oversight in 2025 shows that the agency is watching the GLP-1 space (diabetes, obesity, weight loss drugs) particularly closely, compounded versions or unverified imports will face tough regulatory headwinds.
Clinical trial integrity and manufacturing standards remain high priorities: Violations in GMP, IRB oversight, clinical-trial compliance, misbranding, and more remain top enforcement targets, underscoring the breadth of CDER’s enforcement net.
We’ll be looking at a few things as we head into 2026 here: Will the rise in warning letters continue, or was FY 2025 an outlier reflecting catch-up activity? Will FDA extend “Green List”-style import-control mechanisms beyond GLP-1 APIs, to cover other high-risk drug classes?
How aggressive will the FDA be toward compounded and telehealth-marketed products (especially as demand for alternative formulations remains high)? Will we see more recalls, consent decrees, or escalated enforcement actions as CDER uses its reorganized compliance structure to target repeat offenders or systemic GMP / labeling failures?
A few recommendations
A spike in enforcement signals a shift not just in volume, but in what the FDA believes requires scrutiny. Based on the trends in CDER’s FY 2025 activity, there are a few practical steps regulatory and quality leaders should consider here:
Tighten supply chain and vendor controls. With 126 import alerts and the rollout of the Green List, the FDA has moved upstream. Make sure:
Your API sources are verified and documented.
COAs, audit reports, and qualification evidence are current.
Contract manufacturers and suppliers are inspection-ready—not just compliant on paper.
If third-party reliance has grown faster than oversight, that gap should be closed.
Strengthen GMP discipline, especially around data integrity. More than a third of warning letters cited GMP violations. Small documentation failures including missing contemporaneous entries, incomplete batch records, and inconsistent procedures are showing up repeatedly in the enforcement record. If your SOPs look better than your execution, the FDA will notice.
Evaluate clinical research processes with an emphasis on documentation traceability and IND oversight. Failures to submit INDs and gaps in clinical controls were part of this year’s citations. If you touch clinical data, ask:
Can every data point be traced to source?
Are IRB records current and complete?
Is the boundary between research and marketing clearly guarded?
Need audit or mock inspection support? Let’s talk!
A 50% spike in warning letters isn’t just a headline. It’s a leading indicator. When enforcement intensity increases, gaps that were previously tolerated start showing up in FDA correspondence, on Form 483s, or during pre-approval inspections.
And in many of the warning letters issued this year, the underlying issues weren’t exotic — they were preventable: incomplete documentation, insufficient controls, unvetted suppliers, gaps in clinical oversight, or programs that had drifted away from written procedures.
That’s precisely where proactive auditing makes the difference.
At The FDA Group, our teams conduct:
Mock FDA inspections (including CDER focus areas)
Whether you need a one–time gap assessment, routine coverage, or additional bandwidth to protect timelines, we bring former FDA investigators and experienced industry auditors directly into your process, without adding permanent headcount.
The goal isn’t to prepare for a specific inspection. It’s to operate in a state where a surprise visit doesn’t change your posture. Talk to us.
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