China NMPA Drug Inspection - Huazhou Huayi Traditional Chinese Medicine Pieces Co., Ltd. Traditional Chinese Medicine Pieces Factory - Purple gromwell
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The National Medical Products Administration (NMPA) of China issued an announcement in September 2022 detailing the discovery of 17 batches of non-compliant drugs from 14 pharmaceutical companies. Inspections by various drug testing institutions, including the Hubei Provincial Institute for Drug Control, revealed significant quality control failures.
Key violations included Shanxi Guorun Pharmaceutical Co., Ltd.'s acetylcysteine injection containing unacceptable levels of hydrogen sulfide, and Hubei Tongdetang Pharmaceutical Co., Ltd.'s Huoxiang Zhengqi Water with excessive methanol content. Chrysanthemum, labeled as produced by the China National Institutes for Food and Drug Control, contained residues of prohibited pesticides. Sichuan Yuanshangcao Traditional Chinese Medicine Pieces Co., Ltd.'s Rubia cordifolia failed on appearance and identification, while Lithospermum erythrorhizon from companies like Hebei Honghan Pharmaceutical Co., Ltd. and Xinjiang Enze Traditional Chinese Medicine Pieces Co., Ltd. exhibited non-compliant physical properties.
Under the "Drug Administration Law of the People's Republic of China," the NMPA has mandated that affected enterprises suspend sales and usage of the compromised drugs, initiate recalls, investigate the root causes of non-compliance, and implement corrective actions. Provincial drug regulatory authorities are required to investigate any suspected illegal activities and publicly report their findings, emphasizing the NMPA's commitment to drug safety.
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