# China NMPA Inspection - Chongqing Meiyu Dental Prosthetics Co., Ltd. - June 07, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/chongqing-meiyu-dental-prosthetics-co-ltd/5c1bd6d2-c9ba-4e3b-a658-5f50d0464f8a/
Source feed: China

> China NMPA unannounced inspection for Chongqing Meiyu Dental Prosthetics Co., Ltd. published June 07, 2018. An unannounced inspection of Chongqing Meiyu Dental Prosthetics Co., Ltd., conducted from May 25-26, 2018, by the FDA (NMPA), identified seven complia

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Chongqing Meiyu Dental Prosthetics Co., Ltd.
- Company Name: Chongqing Meiyu Dental Prosthetics Co., Ltd.
- Publication Date: 2018-06-07
- Product Type: Device
- Summary: An unannounced inspection of Chongqing Meiyu Dental Prosthetics Co., Ltd., conducted from May 25-26, 2018, by the FDA (NMPA), identified seven compliance deficiencies. The inspection focused on the company's adherence to Good Manufacturing Practice for Medical Devices and its Appendix for Custom-made Dentures, specifically concerning custom-made fixed dentures. Key issues included critical lapses in material management, where two distinct cobalt-chromium alloys were assigned the same warehouse material code. Production records for raw materials were found incomplete, lacking details like alloy name and casting parameters. Furthermore, essential software systems, including the typesetting and cutting system and wax pattern scanning design software, had not undergone required annual reconfirmation since 2015. Equipment calibration markings on an electronic balance were incomplete, missing equipment numbers and validity dates. The company's raw material testing methods lacked a specified sampling procedure for porcelain blocks. Sales documentation was also deficient, with sales records omitting contact information for sales units and customer files failing to record the validity period of medical practice licenses. Finally, a defined "Product Rework Process" referenced in the rework control procedure was not actually in place. In response, the Chongqing Municipal Food and Drug Administration was directed to mandate the company's rectification of these issues within a set timeframe. This includes assessing product safety risks and, if necessary, recalling potentially unsafe products. Follow-up inspections are to be conducted, and the Chongqing FDA must report the rectification progress to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/chongqing-meiyu-dental-prosthetics-co-ltd/edc3ef33-a6ee-4819-bfcc-9b855b7e3cc0/