First Source Inc – FDA 483, Sep 19, 2023

An FDA inspection of First Source Inc. in Rochester, NY, a medical device manufacturer, identified seven observations related to their iQ Flex M Mobile X-ray System. The firm failed to establish and maintain adequate records for radiation safety testing and did not provide essential product information to purchasers. Additionally, deficiencies were noted in procedures for design changes, corrective and preventive actions, finished device acceptance, and control of nonconforming product.