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Talk to a SpecialistTalk to a SpecialistChem-Tech, Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs, specifically for failing to conduct adequate investigations into out-of-specification (OOS) test results from an external laboratory on an over-the-counter product. The company did not determine root causes for OOS failures, did not implement corrective and preventive actions (CAPA), and provided an inadequate response to FDA's inspection findings that lacked supporting documentation for corrective measures. The violations rendered the drug products adulterated under the Federal Food, Drug, and Cosmetic Act, as the firm's manufacturing methods, facilities, and controls did not conform to CGMP requirements outlined in 21 CFR parts 210 and 211.