TreyMed, Inc.August 27, 2025

FDA 483 - TreyMed, Inc. - August 27, 2025

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Record Details

TreyMed, Inc. in Sussex, WI, was inspected from August 25-27, 2025, and received one observation. The inspection revealed deficiencies in the firm's procedures for controlling nonconforming medical devices. Specifically, documentation and evaluation processes for nonconforming products were found to be inadequate.

Company: TreyMed, Inc.
Inspection Date: August 27, 2025
Product Type: Device
Office: Minneapolis District Office
Person: Shuana H. Xiong

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ID · 7cd7f875-3f7c-4487-95a8-e387402128bb