China NMPA Drug Inspection - Hotan Uyghur Medicine Hospital - Guseyimusak Pills

The Xinjiang Uygur Autonomous Region Food and Drug Administration (XJFDA) announced results in May 2018 from its 2017 drug quality supervision and sampling inspection program. This regional initiative focused on monitoring drugs across the production, distribution, and usage chain, encompassing chemical drugs, traditional Chinese medicine, antibiotics, biochemical drugs, and medical institution preparations.

The inspection identified ten batches of drugs from various manufacturers that failed to meet established quality standards, primarily those outlined in the Chinese Pharmacopoeia or specific regional preparation standards. Key violations included "Non-compliant Solution Color" for Cefuroxime Sodium for Injection produced by Shantou Jinshi Powder Injection Co., Ltd., and "Non-compliant Content" for Huoxiang Zhengqi Water from Sichuan Xuyang Pharmaceutical Co., Ltd. Further issues comprised "Non-compliant Free Hydrazine" in Isoniazid Injection by Tianjin Jinyao Pharmaceutical Co., Ltd., "visible foreign matter" in Ethylphenobarbital Phenylephrine Injection from Shanxi Jinxin Shuanghe Pharmaceutical Co., Ltd., and "Non-compliant pH" or "Content" for preparations from Hotan Prefecture Uyghur Medicine Hospital and Xinjiang Qikang Habo Zhongwei Pharmaceutical Pieces Co., Ltd. Additionally, Hawthorn Pills from Shanghai Sairui Suzhou Pharmaceutical Co., Ltd. showed "Non-compliant Related Substances.

In response, the XJFDA has instructed local regulatory authorities to conduct thorough investigations and apply appropriate penalties against the non-compliant products, manufacturers, and involved operating units, in strict adherence to applicable laws and regulations. This action reinforces the commitment to maintaining stringent drug quality and ensuring patient safety within the region.