# China NMPA Inspection - Tianjin Yangquan Medical Equipment Co., Ltd. - October 30, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-yangquan-medical-equipment-co-ltd/d77150d1-998b-4d06-a3e6-734768900709/
Source feed: China

> China NMPA unannounced inspection for Tianjin Yangquan Medical Equipment Co., Ltd. published October 30, 2018. An unannounced inspection of Tianjin Yangquan Medical Device Co., Ltd., specializing in Disposable Hemoperfusion Devices, was conducted from October 1

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Tianjin Yangquan Medical Device Co., Ltd.
- Company Name: Tianjin Yangquan Medical Equipment Co., Ltd.
- Publication Date: 2018-10-30
- Product Type: Device
- Summary: An unannounced inspection of Tianjin Yangquan Medical Device Co., Ltd., specializing in Disposable Hemoperfusion Devices, was conducted from October 18-19, 2018. The inspection, based on the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices, revealed multiple non-conformities impacting product quality and safety controls.Key violations included significant deficiencies in facility and inventory management, such as improper equipment placement, and the absence of a dedicated inspection/return area in the raw material warehouse. The company also failed to establish adequate control methods for purchasing all material categories. Documentation and record-keeping were found lacking, with incomplete usage records for testing instruments, finished product inspections, and aseptic testing. Critical process changes lacked proper review and verification, and supplier management documents were not correctly approved.Further issues involved inadequate material storage identification, and a failure to analyze the root causes of non-conforming products or implement preventive measures. Sterile product manufacturing showed critical gaps, including the absence of regular monitoring for bacterial and particulate contamination levels, unverified cleanroom personnel limits, and an incomplete water-for-injection system.As a result, the company is mandated to rectify these issues promptly, assess product safety risks, and recall any potentially hazardous products. The Tianjin Municipal Market and Quality Supervision and Management Commission will oversee the rectification process and report compliance to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/tianjin-yangquan-medical-equipment-co-ltd/45c4cba3-0cb0-48d5-80c7-9fe7ac578755/