# China NMPA Inspection - Anhui Guotai Rui Medical Technology Co., Ltd. - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/anhui-guotai-rui-medical-technology-co-ltd/e07f85f7-5494-41a0-8837-9a9aa13958e7/
Source feed: China

> China NMPA unannounced inspection for Anhui Guotai Rui Medical Technology Co., Ltd. published August 15, 2018. An unannounced inspection of Anhui Guotai Rui Medical Technology Co., Ltd., conducted on July 26-27, 2018, by the FDA NMPA, identified 15 general and 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Anhui Guotai Rui Medical Technology Co., Ltd.
- Company Name: Anhui Guotai Rui Medical Technology Co., Ltd.
- Publication Date: 2018-08-15
- Product Type: Device
- Summary: An unannounced inspection of Anhui Guotai Rui Medical Technology Co., Ltd., conducted on July 26-27, 2018, by the FDA NMPA, identified 15 general and several aseptic production deficiencies. The inspection, focusing on the company's Disposable Anorectal Anastomosis Device, was based on the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*.

Key violations included inadequate warehouse management, specifically a lack of segregated areas for product inspection, non-conforming goods, and returns, as well as absent temperature and humidity controls in the finished product warehouse. Documentation inconsistencies were prevalent, affecting the quality manual, cleaning logs, and destruction records for test samples. Deficiencies in process control were noted, with incomplete assembly records and a failure to implement documented sample retention procedures. The company also lacked proper rework control documents and a comprehensive disposal system for non-conforming materials. Internal audit records exhibited inconsistencies and a lack of follow-up on corrective actions.

For aseptic production, issues included ineffective microbiology training, unsuitable cleanroom footwear, and an overdue revalidation of the air conditioning purification system. The company is required to promptly rectify all identified issues, assess product safety risks, and potentially recall any hazardous products. Follow-up inspections and reporting of rectification progress to the National Medical Products Administration are mandated.

Company: https://www.globalkeysolutions.net/companies/anhui-guotai-rui-medical-technology-co-ltd/cbe367b8-a7ed-41b6-bb77-a35fb9576b90/