FDA 483 - Intuitive Imaging Informatics LLC - August 06, 2021

An FDA inspection of Intuitive Imaging Informatics LLC, a medical device manufacturer in Bell Canyon, CA, identified two observations. The inspection found issues with the examination of device labeling for accuracy, specifically regarding the completeness of Unique Device Identifiers (UDI). Additionally, the firm failed to adequately document corrective and preventive action activities from a previous inspection.