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Talk to a SpecialistTalk to a SpecialistHigley Industries, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of over-the-counter drug products at its Dyersville, Iowa facility during a September 2023 inspection. The company failed to adequately test incoming components for identity, purity, strength, and quality, and did not validate the reliability of supplier test analyses at appropriate intervals, instead relying solely on suppliers' certificates of analysis. Notably, the firm failed to test incoming ethanol—used as an active ingredient—for methanol contamination, a deficiency specifically highlighted by the FDA given the serious health risks associated with methanol-contaminated ethanol products. These manufacturing control failures resulted in the company's drug products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act.