China NMPA Drug Inspection - Yunnan Mingjing Hengli Pharmaceutical Co., Ltd. - Compound Berberine Tablets

The Guangxi Zhuang Autonomous Region Food and Drug Administration issued its third Drug Quality Announcement of 2017 on May 3, 2017, following recent sampling inspections under the Guangxi Drug Sampling Inspection Plan. These inspections targeted drug production, distribution enterprises, and medical institutions to enhance drug quality supervision and protect public medication safety. The findings revealed six batches of drugs failing to meet quality standards, comprising three batches of drug preparations and three batches of traditional Chinese medicine decoction pieces.

Key violations included Guangdong Nanguo Pharmaceutical Co., Ltd.'s Vitamin B6 Injection found with visible foreign matter, Wuhan Jinlian Pharmaceutical Co., Ltd.'s Antiviral Oral Liquid failing characteristic chromatogram tests, and Yunnan Mingjing Hengli Pharmaceutical Co., Ltd.'s Compound Berberine Tablets having an unacceptable appearance. For traditional Chinese medicines, Guangxi Renjitang Traditional Chinese Medicine Decoction Pieces Co., Ltd.'s Chuanposhi exhibited non-compliant properties, and Guangxi Yulin Zhizhen Traditional Chinese Medicine Medicinal Pieces Co., Ltd.'s Galangal and Fritillaria thunbergii failed content determination and dioxide specifications, respectively. These issues violated standards outlined in the Chinese Pharmacopoeia (2010 and 2015 Editions) and regional processing specifications. In response, the administration has ordered immediate control measures, including sealing, seizing, suspending sales, and recalling the substandard drugs, alongside initiating investigations and legal actions against the responsible parties.