China NMPA Drug Inspection - Hebei Union Pharmaceutical CO., LTD. - Angelica dahurica

The Shanxi Provincial Food and Drug Administration, operating under the National Medical Products Administration (NMPA), issued a drug quality announcement on April 16, 2018, detailing findings from recent drug sampling inspections. These inspections targeted drug production, distribution enterprises, and medical institutions within Shanxi province, adhering to the Shanxi Provincial Drug Sampling Plan and the Chinese Pharmacopoeia (2010 and 2015 Editions). A total of 62 batches of pharmaceutical products were found non-compliant: 3 drug preparations and 59 traditional Chinese medicine decoction pieces. Identified manufacturers included entities like Shaanxi Xiangju Pharmaceutical Group, Guangdong Luofu Mountain Baihe Pharmaceutical Factory, Sichuan Deyuan Pharmaceutical Group, and numerous Traditional Chinese Medicine Pieces companies primarily from Anhui, Hebei, and Shanxi. A recurring issue was manufacturers disputing the production of specific non-compliant batches. Key violations encompassed critical quality parameters such as insufficient or inconsistent content determination, improper disintegration times, excessive sulfur dioxide residue, failures in physical properties (e.g., appearance, extractives), and issues with purity (e.g., acid-insoluble ash, total reducing sugar, specific impurities). These deficiencies suggest significant quality control and manufacturing process shortcomings. In response, the Shanxi Provincial Food and Drug Administration mandated immediate control measures, including sealing, seizing, and suspending the sale of all non-compliant drugs. Furthermore, thorough investigations and appropriate punitive actions against the responsible entities were required to ensure public medication safety.