China NMPA Inspection - Guizhou Shengfeng Pharmaceutical Co., Ltd. - August 24, 2018

Guizhou Shengfeng Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration from May 23-25, 2018. This inspection, part of the annual plan for national pharmaceutical enterprises, revealed several critical violations of the "Good Supply Practice for Pharmaceutical Products" (GSP) regulatory framework.

The main issues identified included inconsistencies in temperature and humidity monitoring records, with a lack of corresponding alarm logs despite recorded exceedances. The company also failed to conduct necessary internal audits following significant operational changes, such as modifications to its computer management system and warehouse alterations. A severe violation involved the improper storage of drugs requiring room temperature, specifically, a large-volume parenteral solution warehouse that experienced sustained temperatures below 10 C without adequate control. Furthermore, the company did not strictly comply with national regulations for selling compound preparations containing special drugs and demonstrated inadequate management of returned goods, jeopardizing their quality and safety.

In response to these serious non-compliances, the National Medical Products Administration has mandated the Guizhou Provincial Food and Drug Administration to revoke Guizhou Shengfeng Pharmaceutical Co., Ltd.'s GSP certification. An investigation into the company's suspected illegal and irregular business practices has also been initiated, emphasizing the regulatory body's commitment to upholding pharmaceutical product quality and public health standards.