China NMPA Inspection - Chongqing Xinwen Medical Equipment Co., Ltd. - June 04, 2018

An unannounced inspection of Chongqing Xinwen Medical Device Co., Ltd., conducted from May 8-9, 2018, revealed significant non-compliance with "Good Manufacturing Practice for Medical Devices" and its appendix for implantable devices. The inspection focused on their Shape Memory Rib Encircling Bone Plate product.

Two serious issues were identified. Firstly, a critical discrepancy existed in the phase transition temperature for the main material: supplier agreements and certificates specified 33 ± 3℃, while the registered product standard required 29 ± 3℃, with no documented review of this change. Secondly, significant changes to heat treatment parameters in a critical manufacturing process lacked necessary verification or validation records.

Five general deficiencies were also noted, including uncalibrated testing equipment, insufficient supplier investigation, missing key process parameter records for specific product batches, incomplete batch production and quality control records (e.g., absent 100% factory inspection records for critical parameters), and a failure to conduct required post-market surveillance on implanted products, such as monitoring nickel ion release and long-term patient follow-up.

As a result, the regulatory authority, under the "Regulations on the Supervision and Administration of Medical Devices," ordered immediate production suspension for rectification. The company must assess product safety risks, potentially recall unsafe products, and publicly disclose its rectification status. Production can only resume after all deficiencies are addressed and a successful follow-up inspection is completed.