# China NMPA Inspection - JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-rixin-medical-equipment-co-ltd/944f538f-ab93-40c6-a8c0-eec8843e9dd5/
Source feed: China

> China NMPA unannounced inspection for JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD published August 15, 2018. An unannounced cause-based inspection was conducted on July 26, 2018, at Jiangsu Fulin Medical Equipment Co., Ltd., a manufacturer of Medical Oxygen C

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangsu Fulin Medical Equipment Co., Ltd.
- Company Name: JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD
- Publication Date: 2018-08-15
- Product Type: Device
- Summary: An unannounced cause-based inspection was conducted on July 26, 2018, at Jiangsu Fulin Medical Equipment Co., Ltd., a manufacturer of Medical Oxygen Concentrators. This inspection followed a previous review by the Jiangsu Provincial Bureau on June 26-27, 2018. The main issue identified during the inspection was that the company had ceased all production activities on site. This cessation occurred after the company applied for a production halt on July 13, 2018, which led to the Jiangsu Provincial Bureau publishing a production halt and rectification notice on the same day. The regulatory framework for this inspection included the *Good Manufacturing Practice for Medical Devices* and the *Guiding Principles for On-Site Inspection of Good Manufacturing Practice for Medical Devices*. To resume operations, Jiangsu Fulin Medical Equipment Co., Ltd. is required to submit a comprehensive written report to the Jiangsu Provincial Food and Drug Administration. Production can only recommence after a provincial administration re-inspection confirms full compliance with all regulatory requirements. The Jiangsu Provincial Food and Drug Administration must then promptly notify the National Medical Products Administration's medical device regulatory department about the company's resumption of production. The company is expected to uphold its commitment to quality and safety, analyze root causes, assess risks, and implement necessary controls.

Company: https://www.globalkeysolutions.net/companies/jiangsu-rixin-medical-equipment-co-ltd/36bfd0f2-e5bf-4044-bb58-6d8484820f17/