FDA WARNING_LETTER - Woodbine Products Company - February 13, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to Woodbine Products Company Inc. following an inspection of its Medina, Ohio facility conducted from February 9 to 13, 2026. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, resulting in the firm’s over-the-counter (OTC) drug products being classified as adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations include a failure to perform essential identity testing on high-risk chemical components such as glycerin, propylene glycol, and ethanol. This lack of testing creates a major safety risk for contamination with toxic substances like diethylene glycol (DEG) or methanol. Additionally, the firm failed to validate its manufacturing and cleaning processes, utilized a water system unsuitable for pharmaceutical use, and maintained a Quality Control Unit that lacked adequate oversight, stability testing programs, and proper batch records.

To address these deficiencies, the FDA requires Woodbine to submit a comprehensive remediation plan, including independent reviews of material systems and supplier qualifications. The company must conduct thorough risk assessments and retrospective impurity testing for all products currently on the market. Furthermore, the FDA mandates the implementation of robust process validation protocols and strongly recommends hiring a qualified CGMP consultant to bring the facility into compliance. Failure to resolve these issues promptly may lead to legal action, including product seizures or injunctions.