# China NMPA Inspection - Tianjin Vivadentech Technology Co., Ltd. - October 22, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-vivadentech-technology-co-ltd/b544701b-b85f-4127-ad7b-37d16a54c5bc/
Source feed: China

> China NMPA unannounced inspection for Tianjin Vivadentech Technology Co., Ltd. published October 22, 2018. An unannounced inspection of Tianjin Vivadentech Technology Co., Ltd., conducted on September 20-21, 2018, revealed significant non-compliance with th

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Flight Inspection of Tianjin Vivadentech Technology Co., Ltd.
- Company Name: Tianjin Vivadentech Technology Co., Ltd.
- Publication Date: 2018-10-22
- Product Type: Device
- Summary: An unannounced inspection of Tianjin Vivadentech Technology Co., Ltd., conducted on September 20-21, 2018, revealed significant non-compliance with the Good Manufacturing Practice for Medical Devices. The inspection identified seven defects, comprising six critical and one general issue, indicating severe deficiencies in the company's quality management system for Fiberglass Piles.

Key violations included a management representative primarily engaged in sales and R&D, not fulfilling quality system responsibilities, and inadequate employee awareness of compliance. The company lacked essential testing equipment for X-ray resistance and failed to include critical performance indicators like X-ray resistance, bond strength, and composition in product design outputs and inspection procedures. Furthermore, actual production processes deviated significantly from documented procedures, and crucial production records were incomplete, missing details like batch quantities and process parameters. A newly added 'curing' process was implemented without proper design change control or impact verification.

Due to these serious findings, the company was ordered to immediately suspend production for rectification, assess product safety risks, and recall any potentially hazardous products. The regulatory authority mandated publication of the company's status and required a successful follow-up inspection before production could resume, emphasizing strict adherence to the 'Regulations on the Supervision and Management of Medical Devices'.

Company: https://www.globalkeysolutions.net/companies/tianjin-vivadentech-technology-co-ltd/e8075fc3-b2d3-4b71-b743-5ff3733876e0/