FDA 483 - IVIMEA LLC - March 31, 2026

An FDA inspection of IVIMEA LLC in Pennington, NJ, a manufacturer of medical laser devices, revealed 17 significant deficiencies in its quality management system. Observations included a widespread lack of essential records for production, design validation, and complaint handling, as well as issues with equipment calibration, supplier monitoring, and management review. The firm also failed to comply with specific regulations regarding medical device reporting, unique device identification, laser product labeling, and premarket reporting for its Eclipse 980 and Eclipse VLS devices.