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Guangzhou Four E's Scientific Co., Ltd., an OTC drug manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) regulations, resulting in adulterated drug products. The company's quality control unit did not adequately ensure that manufactured drugs met established specifications for identity, strength, quality, and purity, and failed to provide sufficient oversight of its contract manufacturing organization to verify CGMP compliance. These deficiencies were identified through FDA's review of records submitted in response to a March 2024 inspection request.