FDA 483 - Prove Labs Inc. - April 17, 2024

Prove Labs Inc. in Brooklyn, NY, was inspected by the FDA, resulting in six observations primarily concerning inadequate quality system procedures for their medical device software. The inspection revealed deficiencies in design change documentation, lack of written procedures for MDRs, complaint handling, quality audits, and management reviews. Additionally, the firm failed to obtain a Unique Device Identifier for its FitCam Health app.