FDA 483 - Core Health and Fitness, LLC - September 11, 2025

Diversified Healthcare Development LLC, a manufacturer of Korebalance and KoreSway devices in Independence, VA, was cited for six significant deficiencies during an FDA inspection. The firm failed to adequately implement risk analysis, validate device software, establish equipment calibration procedures, conduct management reviews, perform quality audits, and control suppliers. These issues indicate systemic problems in their quality system.