China NMPA Inspection - Inner Mongolia Tengyitang Pharmaceutical Co., Ltd. - August 24, 2018

Inner Mongolia Tengyitang Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration from May 24-26, 2018, as part of an annual plan for national pharmaceutical enterprises. The inspection uncovered numerous significant violations of the "Good Supply Practice for Pharmaceutical Products." Key issues identified included an incomplete computer system lacking essential supplier and purchasing unit data, and a critical failure to implement warnings or controls for expired supplier authorizations, allowing continued procurement. The company's quality manager was found to be concurrently employed at an external health center, and a submitted validation report for temperature and humidity monitoring contained falsified personnel dates and an incorrect facility layout. Warehouse conditions were severely deficient, lacking proper heating and relying on an ineffective manual method of pouring water for humidity control. Furthermore, a traditional Chinese medicine warehouse had been improperly repurposed with non-company equipment. Computer system settings were inadequate, granting management personnel excessive permissions and disabling vital audit functions for qualifications. Additionally, receiving personnel also performed cashier duties, indicating a lack of appropriate segregation of responsibilities. Due to these serious breaches, the National Medical Products Administration mandated the revocation of the company's Good Supply Practice certification and initiated an investigation into suspected illegal and irregular business practices.