483
Viax Dental LabFDA 483 - Viax Dental Lab - August 23, 2018
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Viax Dental Lab, a medical device manufacturer in Alajuela, Costa Rica, received a Form FDA 483 with three observations. The inspection revealed deficiencies in design change procedures, improper labeling of Class IV laser products, and failure to submit a required annual report for a device. These findings indicate issues with the firm's quality system and regulatory compliance.
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