China NMPA Inspection - Hangzhou Jiuyuan Gene Engineering Co., Ltd. - July 16, 2018

An unannounced inspection of Hangzhou Jiuyuan Gene Engineering Co., Ltd., a producer of Bone Repair Materials, was conducted on June 28-29, 2018. The inspection, based on Good Manufacturing Practice for Medical Devices and its Appendix for Implantable Medical Devices, revealed nine general deficiencies across various areas of the facility.

Key issues included significant lapses in facility and equipment management, such as unprotected gas cylinders, expired fire extinguishers, and an insect infestation within a Class 100,000 clean area. Material handling deficiencies were also noted, with "Pending Inspection" and "Qualified" raw materials mixed, unlabelled finished products in cold storage, and altered storage records lacking proper explanations. Furthermore, quality control shortcomings were identified, including the absence of required third-party clean area testing since February 2016, and a lack of usage records for critical equipment like a shaking incubator. An uncontrolled sample retention refrigerator and missing temperature/humidity instrumentation in a calibration room also highlighted control issues.

The Zhejiang Provincial Food and Drug Administration has ordered the company to rectify all identified problems within a specified timeframe. Hangzhou Jiuyuan Gene Engineering Co., Ltd. must also assess product safety risks and initiate recalls for any products deemed hazardous. Follow-up inspections will be conducted, and the provincial authority is required to report the company's rectification efforts to the National Medical Products Administration.