China NMPA Inspection - Shaanxi Yisheng Medical Equipment Co., Ltd. - January 09, 2018

An unannounced inspection of Shaanxi Yisheng Medical Equipment Co., Ltd. took place from November 20th to 21st, 2017, to assess compliance with the *Good Manufacturing Practice for Medical Devices*. The inspection revealed 24 deficiencies, comprising 11 critical and 13 general findings, indicating significant gaps in the company's quality management system.

Key issues included a profound lack of documentation for quality management. The company could not provide purchase records, initial supplier reviews, incoming goods inspections, or in-stock maintenance records spanning from March 2015 to the inspection date, which severely compromised product traceability and inventory reconciliation. Furthermore, the appointed quality manager lacked formal documentation regarding their appointment and responsibilities and demonstrated a lack of awareness of current medical device regulations. After-sales service personnel also had not received necessary technical training.

Operational shortcomings extended to the warehouse, which lacked proper functional area demarcation, signage, essential storage equipment, and pest control measures. Temperature and humidity monitoring devices within the consumables warehouse were uncalibrated, and overall facility maintenance protocols were absent. The company also lacked a computer information management system. These findings necessitate immediate and comprehensive corrective actions to establish and maintain an effective and compliant quality management framework.