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YangZhou SuXiang Medical Instrument Co., Ltd., a Chinese manufacturer of over-the-counter drug products, violated Current Good Manufacturing Practice (CGMP) regulations by failing to conduct adequate identity testing on incoming components used in their drug manufacturing, as required by 21 CFR 211.84(d)(1). The company could not demonstrate scientific evidence that raw materials conformed to appropriate specifications prior to use in manufacturing OTC products including medicated pads. This compliance failure rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act, as their methods, facilities, and controls did not meet CGMP standards.