# China NMPA Inspection - Lanzhou Rongguang Dental Prosthetics Center - June 19, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/lanzhou-rongguang-dental-prosthetics-center/902e7ae5-070c-4541-aad4-3e88209ed6be/
Source feed: China

> China NMPA unannounced inspection for Lanzhou Rongguang Dental Prosthetics Center published June 19, 2018. An unannounced inspection of Lanzhou Rongguang Dental Prosthesis Manufacturing Center, conducted from May 22-23, 2018, by the Gansu Provincial Food an

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Lanzhou Rongguang Dental Prosthetics Center
- Company Name: Lanzhou Rongguang Dental Prosthetics Center
- Publication Date: 2018-06-19
- Product Type: Device
- Summary: An unannounced inspection of Lanzhou Rongguang Dental Prosthesis Manufacturing Center, conducted from May 22-23, 2018, by the Gansu Provincial Food and Drug Administration, revealed significant non-compliance with the *Good Manufacturing Practice for Medical Devices* and its appendix for *Custom-Made Dentures*. The inspection identified five serious defects and thirteen general deficiencies.

Key serious violations included the absence of re-evaluation provisions for qualified suppliers, the use of expired product registration numbers on instruction manuals, and a lack of specified disinfection procedures for incoming dental models, compounded by the absence of required ozone and ultraviolet disinfection equipment. Furthermore, the company failed to establish proper management regulations for sales units, resulting in incomplete sales files and missing qualification certificates for medical institutions. Regulations for the disinfection and review of returned products were also absent.

General deficiencies highlighted issues like inadequate warehouse material management, missing maintenance procedures for critical production equipment, and a lack of risk management integration into design control. Personnel qualification discrepancies and improper hazardous material storage were also noted.

As a result, Lanzhou Rongguang Dental Prosthesis Manufacturing Center was ordered to immediately cease production for rectification. The company must address all violations, assess product safety risks, and initiate recalls for any potentially hazardous products. Production resumption is contingent upon complete rectification and a successful follow-up inspection, with progress to be publicly disclosed.

Company: https://www.globalkeysolutions.net/companies/lanzhou-rongguang-dental-prosthetics-center/d2b2ce14-a794-4da5-98d7-92f534b99c1c/