FDA 483 - Fundus Photo, LLC - March 26, 2025

An FDA inspection of Fundus Photo, LLC in Saint Louis, MO, revealed a significant issue regarding medical device labeling. The firm was cited for failing to apply unique device identifiers (UDI) to its Fundus Photo Digital Imaging System, a Class II medical device, on its hardware, software, and packaging. This indicates a non-compliance with UDI regulatory requirements.