China NMPA Inspection - Shanxi Wanglong Pharmaceutical Group Co., Ltd. - January 20, 2017

Shanxi Wanglong Pharmaceutical Group Co., Ltd. was subject to an unannounced inspection by the State Food and Drug Administration on December 12-13, 2016, following a prior inspection in November 2016 by the Shanxi Provincial Drug Administration. The inspection uncovered critical violations of China's Drug Administration Law and Good Manufacturing Practice (GMP) regulations, specifically impacting the production of Hericium erinaceus Jianweiling Capsules.

Key issues identified included severe mismanagement of Hericium erinaceus strains, evidenced by a lack of proper identification, untraceable propagation records, and inconsistencies in batch documentation. Crucially, the Hericium erinaceus mycelial culture process was not integrated into the company’s GMP-certified quality assurance system. This omission led to disorganized operational control, inadequate documentation, and reliance on operator experience for critical production steps. The inspection also revealed discrepancies in mycelium production records, with batches lacking essential documentation and production schedules being disputed by technicians. Furthermore, the company exhibited poor control over reference materials, lacking preparation records, batch numbers, or expiration dates. A significant finding was the failure of Hericium erinaceus mycelium to meet required enzyme activity standards during an on-site test, contradicting the company's internal quality reports.

In response, regulatory authorities have ordered the revocation of the company's GMP certificate for the affected capsule products. The company is also required to implement necessary risk control measures for products already in distribution, and further investigations into suspected illegal production practices are underway.