China NMPA Drug Inspection - Shaanxi Guangtaihe Pharmaceutical Co., Ltd. - Cimicifuga
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The Gansu Provincial Food and Drug Administration announced on January 17, 2018, the results of targeted supervision and sampling inspections of Traditional Chinese Medicine (TCM) decoction pieces. These inspections focused on products with a history of non-compliance, prominent issues of adulteration and counterfeiting, and concerns regarding dyeing, weight-increasing, or sulfur fumigation. Acting under the "Drug Administration Law of the People's Republic of China" and its implementing regulations, the inspections identified 16 batches of TCM decoction pieces from multiple manufacturers as substandard. Key violations included an expired production license and cancelled Drug GMP certificate for Longxi Yikang Pharmaceutical Co., Ltd., alongside failures to meet *Chinese Pharmacopoeia* standards for properties, content determination, appearance, impurities, total ash, acid-insoluble ash, and sulfur dioxide residue across various products. Regulatory authorities have initiated control measures, including sealing and seizing substandard products. Sampled units are mandated to suspend sales and use, and undertake rectification. Furthermore, municipal food and drug administration departments are required to investigate and prosecute illegal activities in accordance with specific articles of the Drug Administration Law, publicly disclose handling results within three months, and report findings to the Provincial Bureau to ensure public medication safety.
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