FDA Warning Letter Cites Major CGMP Failures in OTC Drug Manufacturer

The FDA’s April 9, 2025 Warning Letter revealed serious CGMP violations at a U.S. OTC drug maker after an October-November 2024 inspection. The firm failed to test high-risk raw materials like glycerin, propylene glycol, and ethanol for toxic contaminants such as diethylene glycol, relying only on supplier certificates.

No stability data supported product expiry dates, and the company lacked a written stability program. Process and equipment validations were missing for liquid OTC hand sanitizers and antibacterial soaps, with unstudied critical parameters and no cleaning validation.

Quality oversight was inadequate, with missing written procedures, absent annual product reviews, and weak data integrity controls. The FDA recommended corrective actions and advised hiring a GMP consultant. Failure to comply could lead to further regulatory action.

28-05-2025