China NMPA Drug Inspection - Xi"an Zaolutang Pharmaceutical Group Co., Ltd. - Bamboo Yellow

The Shaanxi Provincial Food and Drug Administration published an announcement on November 28, 2017, detailing the results of drug quality sampling inspections conducted across the province. These inspections identified 30 batches of drugs that were non-compliant with established quality standards. Key manufacturers implicated in these findings include Shaanxi Kangjing Pharmaceutical Co., Ltd., Shaanxi Duoyao Traditional Chinese Medicine Pieces Co., Ltd., Baoji Xiangyuan Traditional Chinese Medicine Pieces Co., Ltd., Shaanxi Kang Shengtang Pharmaceutical Co., Ltd., Shaanxi Kangyu Pharmaceutical Co., Ltd., Shaanxi Xingshengde Pharmaceutical Co., Ltd., Xi'an Shengwei Pharmaceutical Co., Ltd., Shaanxi Shengxing Traditional Chinese Medicine Pieces Co., Ltd., and Baoji Hanfang Traditional Chinese Medicine Pieces Co., Ltd., among others. While specific inspection dates for each batch are not provided, the announcement consolidates outcomes from these provincial sampling activities.

The primary deficiencies identified related to product properties, identification, general inspection criteria, content determination, and extractives. These violations were assessed against the regulatory standards outlined in the Chinese Pharmacopoeia (primarily the 2015 and 2010 editions, Part I) and the Shaanxi Provincial Standards for Traditional Chinese Medicine Pieces (2008 edition). In response to these non-compliances, relevant local food and drug regulatory departments have implemented necessary control measures for the affected entities and are conducting further investigations and enforcement actions as mandated by applicable laws and regulations.