FDA 483 - Altimate Medical, Inc. - May 22, 2025

An FDA inspection of Altimate Medical, Inc. in Morton, MN, a medical device manufacturer, revealed a significant issue with their complaint investigation records. Specifically, 100% of the reviewed complaint investigations were missing the unique device identifier (UDI), indicating a systemic problem with record-keeping practices. This suggests a lack of complete information for tracking and managing product complaints.