China NMPA Inspection - Guangxi Guiyu Pharmaceutical Co., Ltd. - August 24, 2018

An unannounced inspection of Guangxi Guiyu Pharmaceutical Co., Ltd. was conducted by the Verification Center of the State Food and Drug Administration from May 24 to May 26, 2018. This inspection, part of the annual plan for national pharmaceutical enterprises, revealed several serious violations of the "Good Supply Practice for Pharmaceutical Products." Key issues included the company's failure to issue invoices for certain drug sales, exemplified by a transaction in June 2017 where 300 bottles of compound glycyrrhiza tablets were sold without proper documentation. Furthermore, significant deficiencies were identified in the company's storage conditions, specifically an extended period where the cool storage room maintained excessively high temperatures, ranging from 20℃ to 31℃, compromising drug integrity. A major safety concern was also noted in the warehouse designated for specially managed drugs, where an unauthorized door connected it to an adjacent room, creating a security risk. In response to these findings, the National Medical Products Administration has instructed the Guangxi Zhuang Autonomous Region Food and Drug Administration to revoke Guangxi Guiyu Pharmaceutical Co., Ltd.'s "Good Supply Practice for Pharmaceutical Products" certification. Additionally, an investigation into the company's suspected illegal and irregular business practices has been initiated to address these serious compliance breaches.