483
Altimate Medical, Inc.Altimate Medical, Inc. – FDA 483, May 22, 2025
Record Details
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.
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ID · 696b0c46-81e6-4cc6-ac9a-c3305768cf7b
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