China NMPA Inspection - Qingyuan Jiaxing Pharmaceutical Co., Ltd. - March 27, 2015

On January 23, 2015, Qingyuan Jiaxing Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the Guangdong Provincial Food and Drug Administration and the Qingyuan Municipal Bureau. This inspection was part of a special campaign to regulate the production and sale of traditional Chinese medicine (TCM) decoction pieces. The investigation uncovered serious regulatory violations.

The company was found illegally producing and repackaging various TCM decoction pieces, including aconite, angelica, centipede, North American ginseng, and apricot kernels, at unauthorized facilities. These locations also contained significant quantities of raw materials, packaging, and invoices from other pharmaceutical companies, indicating extensive illicit operations. Furthermore, the company exhibited severe deficiencies in its quality management system, failing to audit suppliers, ensure quality department oversight during material acceptance, or maintain proper records for procurement, acceptance, maintenance, and outbound verification of TCM decoction pieces. Financial irregularities were also noted, with some drug sales lacking appropriate VAT invoices, leading to discrepancies in financial reporting.

In response to these findings, the Guangdong Provincial Food and Drug Administration revoked Qingyuan Jiaxing Pharmaceutical Co., Ltd.'s Good Manufacturing Practice (GMP) Certificate. The Qingyuan Municipal Bureau launched an investigation into the illegal activities, and all suspected criminal offenses have been escalated to public security authorities for further legal proceedings.