FDA 483 - Pro2Health, Inc. - December 18, 2025

An FDA inspection of Pro2Health, Inc. in Lakewood, OH, a medical device manufacturer, identified two significant observations. The firm failed to adequately verify design outputs against inputs, specifically lacking justification for numerous failing tests. Additionally, Pro2Health, Inc. did not provide the required Unique Device Identification (UDI) for its class 2 respiratory muscle training device.