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

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-shuangjian-technology-co-ltd/5bd28676-6c1a-4356-a6a5-1e56f1f4ac6c/
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> 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 (NMPA) of Guangxi Changxin Technology Co., Ltd. uncovered significant defici

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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: Device
- Summary: A recent unannounced inspection by the State Food and Drug Administration (NMPA) of Guangxi Changxin Technology Co., Ltd. uncovered significant deficiencies across its quality management system, in violation of the Good Manufacturing Practice for Medical Devices and its related appendices.

Key issues in "Organization and Personnel" included an inconsistent management representative, a quality department head unfamiliar with essential testing procedures, and a quality inspector lacking required professional knowledge for physical, chemical, and biological testing. Additionally, expired hand sanitizers and out-of-date cleanroom employee health certificates were noted.

Regarding "Factory and Facilities," the inspection found a disorganized raw material warehouse with unqualified and recalled items mixed with miscellaneous goods. The production environment suffered from weeds, stagnant water, and construction waste, alongside an unsafe ethylene oxide storage area adjacent to dormitories. Critical cleanroom issues included a lack of differential pressure monitoring between cleanroom areas, improper storage of cleaning tools, and non-compliant safety doors with locks and excessive steps.

"Equipment" deficiencies comprised incorrect status markings on production machines, the absence of a necessary illuminance meter, and missing usage records for the particle counter. An uncalibrated platform scale and non-compliant purified water piping further highlighted equipment management failures.

"Document Management" issues involved mixed production records in storage, absent batch numbers on raw material location cards, and altered temperature and humidity monitoring records, compromising traceability and integrity. Finally, "Design and Development" revealed a lack of samples and batch production records for specific product models (HJZ-01 and HJZ-02).

Guangxi Changxin Technology Co., Ltd. is required to rectify all identified non-conformities to ensure full compliance with medical device manufacturing regulations.

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