# China NMPA Inspection - Dongguan Dingyuan Ceramic Tooth Products Co., Ltd. - May 28, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/dongguan-dingyuan-ceramic-tooth-products-co-ltd/c3d74042-f408-46ac-a8d7-a8d818e7ac7a/
Source feed: China

> China NMPA unannounced inspection for Dongguan Dingyuan Ceramic Tooth Products Co., Ltd. published May 28, 2018. Dongguan Dingyuan Dental Products Co., Ltd. underwent an unannounced compliance inspection from May 10-11, 2018. Based on the *Good Manufacturing Prac

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Dongguan Dingyuan Ceramic Tooth Products Co., Ltd.
- Company Name: Dongguan Dingyuan Ceramic Tooth Products Co., Ltd.
- Publication Date: 2018-05-28
- Product Type: Device
- Summary: Dongguan Dingyuan Dental Products Co., Ltd. underwent an unannounced compliance inspection from May 10-11, 2018. Based on the *Good Manufacturing Practice for Medical Devices* and its appendix for *Custom-made Dentures*, the inspection revealed 10 significant deficiencies related to the production of custom-made fixed dentures. The regulatory framework focused on ensuring quality and safety in medical device manufacturing. 

Main violations included a widespread lack of essential records, such as documentation for the use of measuring equipment and critical design and development conversion activities for all-ceramic and metal-ceramic restorations. Procedural shortcomings were evident in product protection, contamination control, personnel health management (e.g., physical examination details), and disinfection protocols for work surfaces. The company also failed to establish systems for managing metal raw materials when supplier test records were unavailable, and lacked clarity in specifying material information for all-ceramic restorations. Further issues involved inadequate analysis of deviations from calibration certificates for testing equipment and unspecified methods for determining "standard dosage per unit" in metal balance rate calculations, alongside undefined actions for out-of-limit rates or processing of recovered metals.

Consequently, the Guangdong Provincial Food and Drug Administration has mandated the company to rectify all identified issues within a specified period, assess product safety risks, and initiate recalls for any potentially hazardous products. Follow-up inspections will be conducted, and the provincial authority must report the rectification progress to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/dongguan-dingyuan-ceramic-tooth-products-co-ltd/ea08cdda-4f7e-417c-865c-adf33b1464ff/