FDA 483 - Caliber Imaging and Diagnostics, Inc. - February 06, 2025

Caliber Imaging and Diagnostics, Inc. in Rochester, NY, was inspected by the FDA from February 4-6, 2025. The inspection revealed one observation concerning the firm's quality system. Specifically, the company failed to establish procedures for corrective and preventive actions, neglecting to investigate the root cause of non-conformities for its VivaScope 3000 device.