# China NMPA Inspection - Bauhinia Dental Equipment (Shenzhen) Co., Ltd. - May 28, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/bauhinia-dental-equipment-shenzhen-co-ltd/edd806eb-404b-46af-9a58-71b49d183c3c/
Source feed: China

> China NMPA unannounced inspection for Bauhinia Dental Equipment (Shenzhen) Co., Ltd. published May 28, 2018. An unannounced compliance inspection was conducted on Bauhinia Dental Instruments (Shenzhen) Co., Ltd. from May 8-9, 2018. The inspection, based on th

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Bauhinia Dental Instruments (Shenzhen) Co., Ltd.
- Company Name: Bauhinia Dental Equipment (Shenzhen) Co., Ltd.
- Publication Date: 2018-05-28
- Product Type: Device
- Summary: An unannounced compliance inspection was conducted on Bauhinia Dental Instruments (Shenzhen) Co., Ltd. from May 8-9, 2018. The inspection, based on the Good Manufacturing Practice for Medical Devices and its Appendix for Customized Dentures, identified 12 critical deficiencies in the company's operations. Key violations included the absence of established cleaning procedures and usage records for manufacturing equipment (e.g., LAVA CNC500) and testing instruments (e.g., 8x magnifying glass). The company failed to properly document alterations in raw material testing records. Essential process verification records for the porcelain coating process were absent, and product identification and protection control procedures lacked specific requirements. Additionally, deviations from calibration certificates for testing instruments were not analyzed, and design sheets were incomplete regarding raw material specifications. The inspection also uncovered issues with sterilization equipment usage tracking, waste material management, the absence of a material balance operating manual, and incomplete testing requirements for raw materials like zirconia dental powder. Consequently, the Guangdong Provincial Food and Drug Administration has mandated that Bauhinia Dental Instruments rectify all identified issues within a specified period. The company must analyze root causes, assess product safety risks, implement necessary control measures, and potentially conduct product recalls if safety hazards are identified. Follow-up inspections may occur, and a rectification report must be submitted to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/bauhinia-dental-equipment-shenzhen-co-ltd/90328a7b-a3ac-47f3-aab4-28a21c744a32/