China NMPA Inspection - Shandong Zhongjia Huayang Pharmaceutical Co., Ltd. - August 24, 2018

An unannounced inspection conducted by the State Food and Drug Administration's Verification Center from May 24 to May 26, 2018, revealed significant non-compliance issues at Shandong Zhongjia Huayang Pharmaceutical Co., Ltd. The inspection, part of the annual plan for national pharmaceutical business enterprises, found that the company's warehouse had been demolished in November 2017, rendering it unsuitable for pharmaceutical storage. Furthermore, the company had ceased operations, and its registered address was under renovation, with the actual office located elsewhere. The computer system was malfunctioning, and only a minimal staff, including the person in charge, accountant, and invoice clerk, were present. These critical deficiencies indicated that Shandong Zhongjia Huayang Pharmaceutical Co., Ltd. no longer met the essential conditions for pharmaceutical business operations. Consequently, these actions were deemed non-compliant with the "Good Supply Practice for Pharmaceutical Products" (GSP). The National Medical Products Administration (NMPA) has instructed the Shandong Provincial Food and Drug Administration to revoke the company's GSP certification and to initiate an investigation into its suspected illegal and irregular business practices.