Vincent Medical Holdings Limited (“Vincent Medical” or the “Company”, together with its subsidiaries, the “Group”, stock code: 1612), a global medical devices and solutions provider, is pleased to announce that its wholly-owned subsidiaries Vincent Medical (Dong Guan) Manufacturing Co., Ltd. has successfully completed a Risk-Based Work Plan Inspection conducted by the United States Food and Drug Administration (FDA). The Company has received the “No Action Indicated”* classification.
The evaluation is based on a risk-based Level II Quality System Inspection Technique (QSIT) work plan inspection for ventilator manufacturers. During the five-day inspection, the FDA’s officer meticulously examined Vincent Medical’s procedures, manufacturing practices and protocols, reaffirming the Company’s adherence to the required documentation and manufacturing standards.
Mr. Choi Man Shing, Chairman of Vincent Medical, said, “We are delighted to receive such positive feedback from the FDA inspection. The FDA thoroughly inspected our manufacturing procedures, record and facilities, and their recognition validates our dedication to maintaining manufacturing integrity and comprehensive documentation practices. This successful inspection not only underscores our robust processes and high-quality products, but also enhances our standing as a reliable partner to our customers. I am proud of my team for consistently meeting FDA requirements, and we will maintain our drive to pursue excellence, creating more values for our partners and patients.”
*No Action Indicated – NAI, which means no objectionable conditions or practices were found during the inspection.
– END –