China NMPA Drug Inspection - Guangxi Nanning Dezhi Pharmaceutical Co., Ltd. - Codonopsis pilosula

The Guangxi Zhuang Autonomous Region Food and Drug Administration (part of the NMPA framework) published an announcement on April 7, 2017, detailing drug quality sampling inspections conducted in the fourth quarter of 2016. These inspections covered drug production and distribution enterprises, and medical institutions across the region, identifying 6 batches of drug preparations and 39 batches of traditional Chinese medicine decoction pieces that failed to meet quality standards. Key violations for drug preparations included issues such as non-compliant content determination (e.g., Guizhou Tiandi Pharmaceutical Co., Ltd., Heilongjiang Beiqi Shenyao), visible foreign matter (Tuotuo Injection Limited Company), incorrect color (Hainan Weikang Pharmaceutical), microbial limits (Shijiazhuang Pharmaceutical Group Guangshi Xitai Nuo), and improper properties or dissolution (Guangxi Hengtuo Group Rensheng). For traditional Chinese medicine decoction pieces, numerous manufacturers faced issues predominantly related to non-compliant appearance, moisture content, inaccurate content determination, excessive sulfur residue or sulfur dioxide, and acid-insoluble ash, as per the Chinese Pharmacopoeia and regional processing standards. Notably, initial findings against Nanning Shengyuan Traditional Chinese Medicine Pieces Co., Ltd. for Polyporus umbellatus were later corrected after retesting confirmed compliance with standards. Operating under the Guangxi Drug Sampling Inspection Plan and guided by the 'Drug Administration Law of the People's Republic of China' and various editions of the 'Chinese Pharmacopoeia,' the Administration mandated immediate control measures. These included sealing, seizing, suspending sales, and recalling substandard drugs. Furthermore, affected units are subject to investigation and penalties in accordance with relevant laws, with ongoing follow-up sampling and testing planned to ensure sustained public medication safety.