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Colonial Dames Company, Ltd received a warning for manufacturing adulterated drug products that failed to comply with Current Good Manufacturing Practice (CGMP) regulations, with specific violations involving two oxygenetix® products (a foundation and acne control product) that were unapproved new drugs introduced into interstate commerce. The company's manufacturing methods, facilities, and controls did not meet CGMP standards outlined in 21 CFR parts 210 and 211, and the products were also misbranded and not properly listed with the FDA as required. Additionally, the company failed to fulfill its drug listing obligations under FDA regulations, which constitutes a prohibited act.