FDA 483 - Viax Dental Lab - August 23, 2018

During an FDA inspection conducted from August 20-23, 2018, Viax Dental Lab, a medical device manufacturer based in Alajuela, Costa Rica, received a Form FDA 483 outlining several observations. The inspection highlighted deficiencies across three key areas. Firstly, the company's procedures for design changes were found to be inadequate, specifically lacking proper documentation for risk analysis or justifications in design change validation reports. Secondly, it was observed that Class IV laser products did not have the required DANGER logotype label permanently affixed to the device, as mandated by federal regulations (21 CFR 1040.10(g)(3)), with labels only present within product packaging. Lastly, Viax Dental Lab failed to submit a necessary annual report for its Lucerna device during 2017, a requirement outlined in 21 CFR 1002.13. These findings indicate non-compliance with aspects of medical device quality system regulations and specific reporting and labeling requirements. Viax Dental Lab is expected to evaluate these observations and implement comprehensive corrective actions to ensure full compliance with all applicable FDA regulations.