FDA Reports Rising GMP Warning Letters and Highlights Compliance Gaps in Drug Manufacturing

The US Food and Drug Administration (FDA) has reported a significant increase in drug-related warning letters, while drawing attention to recurring current Good Manufacturing Practice (cGMP) deficiencies across pharmaceutical and biologics manufacturing facilities.

Speaking at the 2026 PDA/FDA Joint Regulatory Conference, Francis R.W. Godwin of the FDA’s Center for Drug Evaluation and Research (CDER) and Kathleen Jones of the Center for Biologics Evaluation and Research (CBER) discussed emerging compliance concerns and common weaknesses identified during inspections.

According to Godwin, the FDA’s Office of Manufacturing Quality had issued 124 adulteration warning letters as of 8 September 2026. The agency was projected to issue approximately 130 such letters by the end of the fiscal year, potentially marking a record level of enforcement activity.

The increase has been linked to several factors, including closer scrutiny of ophthalmic drug manufacturers, persistent compliance problems in 503B pharmacy compounding operations and the entry of new manufacturers into the over-the-counter drug market. The reduction of the inspection backlog accumulated during the COVID-19 period has also enabled the FDA to direct greater attention towards higher-risk manufacturing sites.

The officials identified inadequate raw-material testing as a continuing concern. Failures involving the substitution of diethylene glycol, ethylene glycol and methanol in pharmaceutical ingredients and components remain significant quality risks.

Other recurring weaknesses include ineffective corrective and preventive actions, insufficient deviation trending and inadequate change-control systems. Jones emphasised the need for independent quality assurance oversight, clearly established root-cause investigations and documented effectiveness checks.

The discussions reinforced the FDA’s focus on identifying systemic manufacturing weaknesses and encouraging companies to address potential compliance problems before they develop into serious quality failures.

16-09-2026