FDA 483 - Michigan Instruments, Inc. - July 31, 2025
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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.
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- Detroit District Office
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ID · 253d77d6-abe6-42f4-b41d-8c285896c902