# China NMPA Inspection - Guangxi Shuangjian Technology Co., Ltd. - July 14, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-shuangjian-technology-co-ltd/6fea1849-c260-4494-9faf-35714cbe5b2d/
Source feed: China

> China NMPA unannounced inspection for Guangxi Shuangjian Technology Co., Ltd. published July 14, 2017. A recent unannounced inspection by the State Food and Drug Administration (SFDA), announced on July 14, 2017, revealed significant quality management 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 106 of 2017 from the State Administration for Market Regulation regarding the suspension of production and rectification of Guangxi Shuangjian Technology Co., Ltd.
- Company Name: Guangxi Shuangjian Technology Co., Ltd.
- Publication Date: 2017-07-14
- Product Type: devices
- Summary: A recent unannounced inspection by the State Food and Drug Administration (SFDA), announced on July 14, 2017, revealed significant quality management system deficiencies at Guangxi Shuangjian Technology Co., Ltd. The inspection identified widespread non-compliance with the Good Manufacturing Practices (GMP) for Medical Devices and associated standards. Main issues included a lack of professional knowledge among quality personnel and failure to adhere to hygiene protocols in clean areas. Facility violations were extensive, encompassing improper material flow, compromised cleanroom integrity (e.g., dripping air vents, insect presence), non-functional pressure differential monitoring, inadequate environmental controls, and unlabeled critical items. Equipment deficiencies involved missing sterilization components in pass-through windows. Documentation management was inconsistent, with discrepancies in production and material records, and a lack of proper design change records or risk analysis. The company also failed to implement its revised supplier evaluation procedures. Production issues involved insufficient material traceability, improper product identification, inadequate protection for intermediate products, and unmanaged waste. Quality control was compromised by uncalibrated equipment, premature product release, inaccurate sample retention logs, shared air systems for critical aseptic areas, and a lack of internal testing capability for purified water. Consequently, the SFDA has mandated Guangxi Shuangjian Technology Co., Ltd. to immediately cease production for comprehensive rectification. The company must assess product safety risks, recall potentially hazardous products, and address all identified regulatory violations. Resumption of production is contingent upon successful completion of all corrective actions and verification by a follow-up inspection from the provincial food and drug administration.

Company: https://www.globalkeysolutions.net/companies/guangxi-shuangjian-technology-co-ltd/93f0f8be-f0db-4fa5-b03a-1aec7f7c3f0e/