China NMPA Inspection - Beijing Purun Medical Equipment Co., Ltd. - June 23, 2017

An unannounced inspection conducted by the State Food and Drug Administration (SFDA) between May 9-10, 2017, identified significant non-compliance issues at Beijing Purun Medical Device Co., Ltd. The inspection, based on the *Good Manufacturing Practice for Medical Devices* and its *Appendix: Sterile Medical Devices*, revealed eight general defects.

Key violations included an employee in a cleanroom lacking a required health certificate. Furthermore, the packaging material warehouse was disorganized, with inner packaging materials for products left unsealed and directly entering the clean area. Inaccurate inventory records were also found for plastic and metal parts. Crucially, essential production process control records, such as cleaning and disinfection logs for clean areas and equipment, and environmental monitoring records, were either missing or incomplete from 2015 to 2017.

In response, Beijing Purun Medical Device Co., Ltd. is mandated to rectify all identified issues promptly and report its compliance efforts to the SFDA. The company must also recall any products posing safety risks. The Beijing Municipal Food and Drug Administration is directed to intensify its daily oversight of the company, conduct follow-up inspections, and ensure stringent adherence to manufacturing practices to safeguard medical device product safety and effectiveness.