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

Source: https://www.globalkeysolutions.net/records/483/altimate-medical-inc/696b0c46-81e6-4cc6-ac9a-c3305768cf7b

> FDA 483 for Altimate Medical, Inc. on May 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Altimate Medical, Inc.
- Inspection Date: 2025-05-22
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Clifford F. Long](https://www.globalkeysolutions.net/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.globalkeysolutions.net/companies/altimate-medical-inc/ec5c030c-988f-45b7-ab24-fb4cc058e422

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d
