China NMPA Inspection - Shaanxi Momed Pharmaceutical Co., Ltd. - October 23, 2014

An unannounced inspection was conducted by the State Drug Administration, a key regulatory body under the National Medical Products Administration (NMPA), at Shaanxi Momede Pharmaceutical Co., Ltd. on August 21 and 22, 2014. The inspection report, published on October 23, 2014, detailed significant findings regarding the company's manufacturing practices. During the inspection, authorities identified suspected violations related to the production of Guanxin Danshen Capsules. Specifically, the company was found to be potentially not adhering to the prescribed formulation and failing to follow established process specifications during the manufacturing of this product. These issues represent serious deviations from regulatory requirements designed to ensure drug quality and safety. In response to these findings, the Shaanxi Provincial Drug Administration has initiated an investigation to thoroughly examine the alleged non-compliances and determine appropriate actions. This ongoing investigation aims to ensure that Shaanxi Momede Pharmaceutical Co., Ltd. addresses all identified deficiencies and complies with pharmaceutical production standards, upholding the integrity of the drug supply chain and patient safety.