China NMPA Product Recall - Ferric ammonium citrate raw material

The National Medical Products Administration (NMPA) issued a notice concerning Chongqing Quanxin Xiangsheng Biopharmaceutical Co., Ltd., following a surprise inspection conducted from December 26 to 29, 2015. The inspection revealed significant quality and manufacturing process issues related to the company's ferric ammonium citrate raw materials. Specifically, the ferric ammonium citrate was found to contain dangerously high levels of chromium, posing a substantial risk to public health. Furthermore, serious deficiencies were identified in the company's overall drug production process, indicating a failure to adhere to established manufacturing standards. Under the regulatory framework outlined in the SFDA Office Letter on Drug and Chemical Supervision [2015] No. 860, the Chongqing Food and Drug Administration was directed to implement several critical actions. These included immediately ordering the company to cease all production and sales of ferric ammonium citrate raw materials and revoking its Good Manufacturing Practice (GMP) certificate for this product. Additionally, the company was mandated to conduct a thorough investigation into the distribution and sales channels of the affected raw material and initiate a comprehensive recall of all products already distributed in the market. Public notification of this recall was also required. The NMPA further instructed a full investigation into any illegal or irregular activities, with strict legal repercussions for any discovered violations. The Chongqing bureau is responsible for reporting all investigation and handling outcomes to the State Administration in a timely manner.