FDA 483 - First Source Inc - September 19, 2023

During an FDA inspection of First Source Inc, a medical device manufacturer in Rochester, NY, conducted from September 14 to September 19, 2023, several compliance deficiencies were identified. The observations pertain to both Electronic Product Radiation Control and the firm’s Quality Management System, operating under the Federal Food, Drug, and Cosmetic Act. Key issues observed for their iQ Flex M Mobile X-ray System included a failure to maintain records for radiation safety test methods, such as linearity and reproducibility. Additionally, the company did not provide critical product information to purchasers, specifically cooling curves for the anode and tube housing, and leakage technique factors. Regarding the Quality Management System, deficiencies were found in design change procedures, with inadequate validation for a significant design modification. The corrective and preventive action (CAPA) process lacked adequate verification of effectiveness for implemented actions. Furthermore, finished device acceptance procedures, including final inspections for X-ray heads, were not properly established, and procedures for controlling nonconforming products were insufficient. First Source Inc has committed to correcting all identified observations.