China NMPA Inspection - Harbin High-Tech Swan Pharmaceutical Group Co., Ltd. - March 16, 2016

An unannounced inspection of Harbin High-Tech Swan Pharmaceutical Group Co., Ltd., conducted from March 7-11, 2016, by the State Food and Drug Administration, revealed significant violations. The inspection, prompted by a complaint, identified critical issues concerning the production of hepatocyte growth factor extract solution. The company's actual production process, specifically involving pepsin hydrolysis, deviated from its officially documented and approved processes. Furthermore, investigators discovered extensive fabrication of batch production, inspection, and material records for multiple batches, with evidence showing these batches were never actually produced. The company also failed to provide original records for numerous other batches from 2014 and 2015, rendering their production untraceable. Laboratory equipment, including high-performance liquid chromatographs and ultraviolet spectrophotometers, showed signs of data fabrication and tampering, lacking proper audit trails and having modified system times. Additionally, deficiencies in raw material procurement were noted; liver was sourced without proper quality agreements or robust quality standards, making traceability and quality control impossible. These actions constitute severe breaches of the "Drug Administration Law" and Good Manufacturing Practice (GMP) regulations. Consequently, the regulatory authorities mandated immediate revocation of the company's GMP certificate, cessation of all production, an investigation into the production and sales of injectable hepatocyte growth factor, and a comprehensive recall of all affected products on the market.