China NMPA Inspection - Zhuhai Funia Medical Equipment Co., Ltd. - August 15, 2018

An unannounced follow-up inspection of Zhuhai Funia Medical Equipment Co., Ltd. took place on July 24-25, 2018. The inspection, conducted under the regulatory framework of Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices, focused on the company's manufacturing processes for its Electronic Micro-infusion Pump.

Key violations included deficiencies in equipment maintenance, such as inconsistent information regarding air filter maintenance, discrepancies in sterilizer maintenance records, unrecorded extruder usage, and failure to adhere to the purified water filter replacement schedule. Production records were also found lacking, specifically concerning the main equipment and process parameters for tubing assembly and the omission of motherboard program burning details. Furthermore, the company failed to label after-sales repair products and lacked proper work instructions for their disinfection, inspection, verification, and for product rework procedures. Cleanroom management issues were identified, including the absence of a designated cleaning room, missing material disinfection records, and incomplete environmental monitoring logs.

As a consequence, Zhuhai Funia Medical Equipment Co., Ltd. is required by the Guangdong Provincial Food and Drug Administration to promptly rectify all identified problems, conduct a thorough assessment of product safety risks, and recall any products that pose potential hazards. Follow-up inspections may be conducted, and the provincial authority must report the company's rectification progress to the National Medical Products Administration.