China NMPA Inspection - Shanghai Promega Biotechnology Co., Ltd. - May 28, 2018

An unannounced inspection of Shanghai Prometheus Bioproducts Co., Ltd. was conducted by the NMPA from May 8-9, 2018. The inspection, based on the regulatory framework of *Good Manufacturing Practice for Medical Devices* and its *Appendix for In Vitro Diagnostic Reagents*, identified nine general deficiencies related to the production of the company's Chlamydia trachomatis Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method).

Key issues included inadequate documentation and traceability, such as untraced self-made plasmids and missing cleaning dates for glassware. Production records for a specific batch lacked details on key equipment used in nucleic acid extraction, and light inspection records for semi-finished products were insufficient. The company also failed to provide regular microbiological training for cleanroom operators and conducted plasmid pretreatment in an unsuitable cleanroom environment. Furthermore, critical areas lacked proper temperature and humidity monitoring, and a significant temperature alarm deviation was not handled according to established procedures. Hand disinfection standard operating procedures were incomplete, and disposal records for intermediate product waste were absent.

As a result, the Shanghai Municipal Food and Drug Administration mandated the company to rectify these issues promptly, assess product safety risks, and recall any products posing potential hazards. Follow-up inspections may occur, and the rectification progress must be reported to the NMPA.