China NMPA Drug Inspection - Henan Shengwang Pharmaceutical Co., Ltd. - Qingkailing Injection

The Guangxi Zhuang Autonomous Region Food and Drug Administration (GXFDA) published an announcement on September 29, 2017, detailing the outcomes of its drug quality sampling inspections. These inspections were carried out under the Guangxi Drug Sampling Plan to safeguard public medication safety by monitoring drug manufacturers, distributors, and medical institutions within its jurisdiction.The inspections identified seven batches of drugs that failed to meet quality standards, comprising four drug preparations and three traditional Chinese medicine decoction pieces. Significant issues for drug preparations included "Visible Foreign Matter" in Inosine Injection and Adenosine Triphosphate Diphosphate Sodium Injection, produced by Guangdong Nanguo Pharmaceutical Co., Ltd., and Qingkailing Injection from Henan Shennong Pharmaceutical Industry Co., Ltd. For traditional Chinese medicine decoction pieces, non-compliance involved issues with a specific chemical test ("Jin An O") for Corydalis Rhizome from Guangxi Sanhetang Pharmaceutical Co., Ltd., and failures in "Properties" and "Identification" (Thin Layer Chromatography) for Sangjisheng Decoction Pieces and Guangfangji Decoction Pieces, both from Nanning Huatai Traditional Chinese Medicine Decoction Pieces Limited Liability Company.The regulatory basis for these assessments included the Chinese Pharmacopoeia (2010 and 2015 editions) and specific regional processing standards. In response, the GXFDA directed municipal food and drug administrations to implement immediate control measures, such as sealing, seizing, and suspending the sale of the substandard drugs. Furthermore, legal investigations and penalties against the responsible suppliers are mandated to ensure adherence to quality standards and protect public health.