# China NMPA Inspection - Jiangxi Sanxin Medical Technology Co., Ltd. - May 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangxi-sanxin-medical-technology-co-ltd/8ab67ab6-c7bf-41ec-a2d8-51e6c25c3f05/
Source feed: China

> China NMPA unannounced inspection for Jiangxi Sanxin Medical Technology Co., Ltd. published May 09, 2018. An unannounced inspection of Jiangxi Sanxin Medical Technology Co., Ltd. was conducted from April 19-20, 2018, under the Good Manufacturing Practice f

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangxi Sanxin Medical Technology Co., Ltd.
- Company Name: Jiangxi Sanxin Medical Technology Co., Ltd.
- Publication Date: 2018-05-09
- Product Type: Device
- Summary: An unannounced inspection of Jiangxi Sanxin Medical Technology Co., Ltd. was conducted from April 19-20, 2018, under the Good Manufacturing Practice for Medical Devices framework. The inspection revealed nine general deficiencies primarily concerning quality and safety controls. Key issues included damaged locks on clean area doors, critical inventory discrepancies, and improper storage and labeling of highly toxic raw materials in the testing laboratory. Furthermore, the company failed to adequately monitor cleanroom air conditioning systems and lacked proper validation data for intermediate product storage. Unrecorded process changes, insufficient supplier oversight regarding cleanroom certifications and material specifications, and inadequate dust prevention and labeling in the powder removal packaging room were also identified. There were also concerns with sample retention practices and a complete absence of a system for destroying non-conforming products. As a result, the company is required to promptly rectify all identified issues, assess product safety risks, and implement necessary risk management measures, including potential product recalls. The Jiangxi Provincial Food and Drug Administration will conduct follow-up inspections and report the resolution to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/jiangxi-sanxin-medical-technology-co-ltd/947586e0-a6fe-4685-8279-bd6c8a0e4b4e/