China NMPA Drug Inspection - Shaanxi Renkang Pharmaceutical Co., Ltd. - Atractylodes lancea

The Shaanxi Provincial Food and Drug Administration, operating under China's National Medical Products Administration (NMPA) framework, issued an announcement on February 9, 2018, detailing the outcomes of its provincial drug quality sampling inspections. Conducted to bolster drug supervision and ensure public medication safety, these inspections identified 13 batches of drugs that failed to meet quality standards. Several manufacturers were implicated, including Baoji Hanfang Guoyao Pieces Co., Ltd., Shaanxi Kangshengtang Pharmaceutical Co., Ltd., Shaanxi Kangchao Kangjian Pharmaceutical Co., Ltd., Shaanxi Kangyu Pharmaceutical Co., Ltd., Shaanxi Xingshengde Pharmaceutical Co., Ltd., and Qingyang Yixiang Pharmaceutical Co., Ltd. The primary violations spanned critical quality attributes such as appearance, identification, purity (inspection parameters), and content determination. Examples included non-compliance with physical properties and active ingredient levels for traditional Chinese medicine ingredients like Pinellia ternata, Stephania tetrandra, Lygodium japonicum, Angelica sinensis root, and various Atractylodes lancea preparations. Compliance assessments were based on official regulatory frameworks, notably the Chinese Pharmacopoeia 2015 Edition, Part I, and the Shaanxi Provincial Standard for Traditional Chinese Medicine Decoction Pieces 2008 Edition. In response, local food and drug regulatory departments have implemented control measures. Investigations are actively proceeding, and appropriate legal and regulatory actions will be pursued against the responsible parties to rectify these quality deficiencies.