China NMPA Inspection - Hunan Hande Minimally Invasive Medical Technology Co., Ltd. - November 20, 2017

An unannounced inspection of Hunan Hande Minimally Invasive Medical Technology Co., Ltd., conducted from November 8-10, 2017, revealed several compliance deficiencies regarding medical device manufacturing practices. The inspection, based on the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices, identified seven main issues. These included improper installation of a temperature and humidity meter in the raw material warehouse, an unsigned maintenance record for the ethylene oxide sterilization system, and an incomplete 'Controlled Status' field on the Quality Manual cover. Further non-compliances involved a missing personnel training record related to product development, an incomplete Product Bill of Materials lacking material categorizations, and an inadequate 'Non-compliance Analysis' and 'Follow-up Verification' in pass rate statistics. Additionally, a newly hired equipment administrator had not received essential training in hygiene, microbiology, and basic knowledge. As a result, the Hunan Provincial Food and Drug Administration has mandated the company to rectify these issues within a defined timeframe, assess product safety risks, and initiate product recalls if safety hazards are identified. The administration is also required to report the company's rectification progress to the State Administration for Market Regulation.