# FDA 483 - Michigan  Instruments, Inc. - July 31, 2025

Source: https://www.keypedia.com/records/483/michigan-instruments-inc/253d77d6-abe6-42f4-b41d-8c285896c902

> FDA 483 for Michigan  Instruments, Inc. on July 31, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michigan  Instruments, Inc.
- Inspection Date: 2025-07-31
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Michigan Instruments, Inc. in Grand Rapids, MI, revealed deficiencies in the firm's complaint investigation records and procedures. Specifically, the firm failed to include Unique Device Identifiers (UDI) in all reviewed complaint investigations for its Class 2 Life-Stat Model 1008MII CPR device, and its complaint handling procedure lacked the requirement for UDI or UPC. This indicates a significant lapse in maintaining complete and accurate device complaint documentation.

## Related Officers

- [Hammam A. Abdallah](https://www.keypedia.com/people/hammam-a-abdallah/fc1ee5c3-b00c-43af-b5a3-1bdc2ad6c5d7)

Company: https://www.keypedia.com/companies/michigan-instruments-inc/17fd8d52-c398-4a8f-8e5c-25e688c0a3c0

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03