China NMPA Inspection - Hangzhou Xiehe Medical Supplies Co., Ltd. - June 07, 2018

An unannounced inspection of Hangzhou Xiehe Medical Supplies Co., Ltd., conducted from May 24-26, 2018, by the NMPA, identified ten general defects regarding their Injectable Cross-linked Sodium Hyaluronate Gel production. The inspection, based on Good Manufacturing Practice for Medical Devices and its Implantable Medical Devices Appendix, revealed several critical non-conformances. Key issues included: a lack of explosion-proof lights and ventilation in the analytical chamber; inconsistent batch numbering in quality control records; missing temperature parameters in crosslinking process verification reports; improper storage of highly toxic reagents; and inadequate corrective and preventive actions for product packaging complaints. Further deficiencies involved cleanroom garment instructions, uncontrolled storage for test syringes, incomplete ethylene oxide sterilizer reconfirmation, unspecified storage/management for moist heat sterilization loading materials, and the absence of sterility testing for long-term stability samples. As a result, the company is required to promptly rectify all identified issues, assess product safety risks, and initiate recalls for any hazardous products. The Zhejiang Provincial Food and Drug Administration will oversee the rectification process, conducting follow-up inspections as needed, and reporting the outcomes to the National Medical Products Administration.