China NMPA Inspection - China Resources Xi'an Pharmaceutical Co., Ltd. - January 25, 2019

An inspection of China Resources Xi'an Pharmaceutical Co., Ltd., conducted by the National Medical Products Administration Audit and Inspection Center from June 21-23, 2018, revealed serious non-compliance with pharmaceutical supply regulations. The audit uncovered multiple critical deficiencies in the company's operations.

Key violations included the failure to issue accurate and timely invoices for drug sales, and the procurement of certain medicines without prior legality review or proper system integration. The company's environmental monitoring system for temperature and humidity did not meet regulatory requirements, lacking proper alarm settings and daily data backups. Furthermore, a significant number of insulated transport boxes (12 out of 17) had not undergone required periodic validation. Storage practices were also inadequate, with non-pharmaceutical items, pharmaceuticals, and different categories of medicines not being appropriately segregated. Finally, deficiencies were noted in the handling of substandard and returned drugs, with incomplete procedures and inadequate computer system tracking.

These systemic failures constituted a serious violation of the "Good Supply Practice for Pharmaceutical Products." As a result, the Shaanxi Provincial Drug Administration revoked China Resources Xi'an Pharmaceutical Co., Ltd.'s Good Supply Practice certification and initiated an investigation into the company's alleged illegal business practices.