China NMPA Inspection - Lanzhou Ximai Memory Alloy Co., Ltd. - August 10, 2017

An unannounced inspection of Lanzhou Ximai Memory Alloy Co., Ltd., conducted from July 20-21, 2017, aimed to assess compliance with Good Manufacturing Practice for Medical Devices and its Appendix for Implantable Medical Devices, along with the Regulations on the Supervision and Administration of Medical Devices. The inspection identified significant deficiencies in the company's quality management system.

Four serious defects were found. These included a failure to update quality management system documents in line with current regulations, inadequate product recall procedures that did not cover all mandated situations, and issues with raw material traceability and documentation. Furthermore, critical manufacturing processes like wire cutting and cleaning were either omitted from official flow charts or lacked proper validation, and essential finished product testing records for memory performance, surface roughness, and hardness were incomplete or lacked original data.

Thirteen general defects were also noted, spanning areas such as cleanroom documentation, equipment maintenance, design control, risk analysis, incomplete batch records, and unclear product release protocols. Significant issues were also identified in the chemical testing laboratory, including inadequate layout, missing reagent preparation details, and insufficient environmental monitoring records.

Consequently, the Gansu Provincial Food and Drug Administration mandated Lanzhou Ximai Memory Alloy Co., Ltd. to immediately cease production and undertake comprehensive rectification. The company must also assess product safety risks and address any violations of the relevant regulations and laws.