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

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-shuangjian-technology-co-ltd/c10e15a1-33b9-4726-86fe-64dc7dd566e2/
Source feed: China

> China NMPA unannounced inspection for Guangxi Shuangjian Technology Co., Ltd. published July 14, 2017. A recent surprise inspection by the State Food and Drug Administration (SFDA) of Guangxi Changxin Technology Co., Ltd., conducted around July 2017, re

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 109 of 2017 from the State Administration for Market Regulation regarding the suspension of production and rectification of Guangxi Changxin Technology Co., Ltd.
- Company Name: Guangxi Shuangjian Technology Co., Ltd.
- Publication Date: 2017-07-14
- Product Type: devices
- Summary: A recent surprise inspection by the State Food and Drug Administration (SFDA) of Guangxi Changxin Technology Co., Ltd., conducted around July 2017, revealed severe deficiencies across its quality management system, leading to a mandatory production suspension.The inspection identified numerous violations of the Good Manufacturing Practices (GMP) for medical devices and associated regulatory standards. Key issues included organizational and personnel shortcomings, such as an inconsistent management representative, lack of familiarity with regulations among quality department heads, and unqualified quality inspectors. Facility problems were extensive, encompassing inadequate storage area management, poor environmental control around the plant, unsafe ethylene oxide storage, and critical cleanroom failures like insufficient differential pressure monitoring and improper waste handling. Equipment issues ranged from incorrect status markings and missing calibration certificates to absent usage records and non-compliant water systems. Furthermore, significant document management flaws were noted, including altered records and missing batch information, impacting product traceability. Production management exhibited a lack of control over intermediate products and inadequate cleanroom protocols, while quality control suffered from premature inspection reports, expired reagents, and shared air conditioning for critical testing areas. Finally, the company lacked a product information notification procedure and failed to assess regulatory applicability in management reviews.Consequently, Guangxi Changxin Technology Co., Ltd. has been ordered to immediately cease production for comprehensive rectification. The company must address all identified deficiencies, assess product safety risks, recall any hazardous products, and will only be permitted to resume manufacturing after successfully passing a follow-up inspection by the provincial food and drug administration.

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