FDA 483 - Long Island Technology Group LLC - January 26, 2024

Long Island Technology Group LLC, a manufacturer of Class II light fixtures, was cited for significant deficiencies in its corrective and preventive action (CAPA) system. The firm failed to adequately document root cause investigations for recurring fan failures and did not properly assess risks or evaluate the effectiveness of corrective actions. This indicates a serious breakdown in their quality system regarding complaint handling and problem resolution.