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Foshan Biours Biosciences Co., Ltd., a manufacturer of over-the-counter drug products, failed to conduct adequate finished drug product testing prior to release, violating current good manufacturing practice (CGMP) regulations under 21 CFR parts 210 and 211. Specifically, the company distributed an OTC patch product into the United States without performing appropriate laboratory testing to confirm the identity and strength of the active ingredient, in violation of 21 CFR 211.165(a). These manufacturing and quality control deficiencies resulted in adulterated drug products as defined under the Federal Food, Drug, and Cosmetic Act.