FDA 483 - JoGo Health - July 30, 2024

An FDA inspection of JoGo Health in Bridgewater, NJ, a specification developer for the JOGO-GX biofeedback device, revealed significant deficiencies in their quality system. The firm failed to document software validation results, establish procedures for finished device acceptance, and implement adequate personnel training programs. These observations indicate fundamental gaps in ensuring product quality and compliance.