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Lex Inc., a drug manufacturer in Medley, Florida, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection conducted in February 2023. The company's quality control unit provided inadequate oversight of over-the-counter drug product manufacturing and failed to establish proper written procedures for quality unit responsibilities, including approval or rejection of components and drug products and review of production records for completeness and errors. Specific deficiencies included the quality unit's inability to ensure adequate authority and responsibility, verify that components and finished products met established specifications for identity, strength, quality, and purity, and properly sample, test, and release lots before use. As a result, the company's drug products were determined to be adulterated under the Federal Food, Drug, and Cosmetic Act due to nonconforming manufacturing methods, facilities, and controls.