FDA 483 - GPS DENTAL LAB, INC - November 05, 2024

An FDA inspection of GPS DENTAL LAB, INC in Orlando, FL, revealed extensive deficiencies in their quality system for manufacturing class 2 medical devices. The firm lacked established procedures for critical areas including complaint handling, nonconforming product control, corrective and preventive actions, equipment calibration, and supplier evaluation. These widespread issues indicate a fundamental failure to ensure devices are produced in accordance with regulatory requirements.