FDA 483 - PT Genie LLC - July 13, 2023

PT Genie LLC in Orlando, FL, a manufacturer of Class 2 medical device software, was inspected by the FDA from July 7-13, 2023. The inspection revealed significant deficiencies across its quality system, including the lack of established procedures for design control, corrective and preventive actions, nonconforming product disposition, document control, complaint handling, and supplier evaluation. These findings indicate a fundamental absence of critical quality system processes for their PT Genie Measuring Exerciser Medical Device Software.