China NMPA Drug Inspection - Zhejiang Zoli Baicao Traditional Chinese Medicine Pieces Co., Ltd. - Angelica pubescens

The National Medical Products Administration (NMPA) of China announced on September 30, 2018, the findings from inspections identifying non-compliance in 17 batches of drugs produced by nine different companies. These inspections, conducted by various provincial drug testing institutions, revealed several critical quality issues.

Key violations included: Henan Dingfukang Pharmaceutical Co., Ltd. for Compound Dexamethasone Acetate Cream, failing on fill volume and content determination; Guangxi Nanning Baihui Pharmaceutical Group Co., Ltd. and Sichuan Deyuan Pharmaceutical Group Co., Ltd. for Piperazine Phosphate Pagoda Sugar, exhibiting weight variation; Yuncheng Shennong Chinese Medicinal Materials Co., Ltd. and Ningxia Mingde Chinese Medicinal Herbs Co., Ltd. for Rehmannia glutinosa, with content determination discrepancies; multiple companies including Yuncheng Shennong and Zhejiang Zuoli Baicao for Angelica pubescens, cited for content determination, sulfur dioxide residue, and identification issues; and Sanmenxia Sainov Pharmaceutical Co., Ltd. for enteric-coated scalp-dissolving capsules, exceeding microbial limits.

These findings were evaluated against established pharmaceutical standards, including the Pharmacopoeia of the People's Republic of China. Regulatory authorities have since initiated control measures such as product recalls, suspension of sales, and seizures. Provincial drug regulatory bodies are mandated to investigate these companies further for producing and selling substandard drugs, in accordance with Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*. The investigation results are required to be finalized and made public within three months.