China NMPA Drug Inspection - Hunan Kangerjia Pharmaceutical Co., Ltd. - Ulcer Capsules

The Xinjiang Uygur Autonomous Region Food and Drug Administration (part of China's NMPA framework) conducted a regional drug quality supervision and sampling inspection throughout 2016. This initiative covered a broad spectrum of pharmaceutical products, including chemical drugs, traditional Chinese medicine, antibiotics, biochemical drugs, and medical institution preparations, sourced from various manufacturers, distributors, and users. The inspection, announced on February 13, 2017, revealed that the first batch of 23 drug batches failed to meet established quality standards. Numerous companies were implicated, including Hunan Mawangdui Pharmaceutical Co., Ltd., Tianjin Jinyao Pharmaceutical Co., Ltd., Shandong Yikang Pharmaceutical Co., Ltd., and Moyu County Uygur Medicine Hospital, among others. Key violations identified across these products primarily involved discrepancies in content or content determination (e.g., Huoxiang Zhengqi Water, Cough Syrup), presence of visible foreign matter (e.g., Sodium Bicarbonate Injection, Isoniazid Injection), issues with appearance (e.g., Aminophylline Injection, Ulcer Capsules), and non-compliance in related substances or identification. The regulatory framework for these assessments included the Chinese Pharmacopoeia 2010 Edition, various national drug standards, and specific regional medical institution preparation standards. As a result, the Xinjiang FDA has directed local food and drug regulatory departments to investigate and penalize the implicated production, operation, and usage units, as well as the non-compliant products, in accordance with applicable laws and regulations. These actions underscore the commitment to maintaining drug quality and safety within the region.