China NMPA Inspection - Sichuan Daqian Pharmaceutical Co., Ltd. - June 20, 2018

Sichuan Daqian Pharmaceutical Co., Ltd. was subject to an unannounced follow-up inspection by the Verification Center of the State Food and Drug Administration and the Ziyang Municipal Food and Drug Administration, Sichuan Province. This inspection, part of a drug inspection plan and published on June 19, 2018, uncovered critical violations in the company's manufacturing processes. The primary issue identified was inaccurate batch production records for Longdan Xiegan Wan, a traditional Chinese medicine. Specifically, batch records (Z-170904, Z-171101, Z-171102) showed significant discrepancies between the recorded and actual processing capacities for key ingredients, such as Angelica sinensis and Glycyrrhiza uralensis. For example, records indicated processing amounts of 104 kg and 105 kg, respectively, while the actual capacity of the frying machine was approximately 70 kg and 80 kg per batch. This demonstrated a failure to maintain accurate and truthful production documentation. These findings indicated that the company's production practices for Longdan Xiegan Wan did not comply with the Good Manufacturing Practice for Pharmaceuticals (2010 revision). Consequently, the Sichuan Provincial Food and Drug Administration was directed to revoke the company's relevant GMP certificates. Additionally, the administration was instructed to investigate and address the company's illegal and irregular activities according to legal provisions.