FDA 483 - CrossRoads Extremity Systems, LLC - August 02, 2019

CrossRoads Extremity Systems, LLC in Memphis, TN, was inspected by the FDA, resulting in four observations. The inspection revealed deficiencies in documenting justifications for not reporting field corrective actions and inadequate complaint handling for MDR reportable events. Additionally, the firm failed to adequately establish complaint procedures and maintain its device master record.