483
JoGo HealthJoGo Health – FDA 483, Jul 30, 2024
Record Details
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.
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ID · 57c591f5-b982-4f32-bd3a-0480f424563e
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