Telemetry company ScottCare has corrected all violations found during a site inspection earlier this year, earning an Aug. 13 closeout letter from the FDA’s Cincinnati District Office. “It appears that you have addressed the violations contained in this [Feb. 21] warning letter,” the agency said, adding further inspections will assess the adequacy and sustainability of those actions. The warning letter followed a Jan. 9-13 inspection of ScottCare’s Cleveland, Ohio, facility. Inspectors reported a series of GMP lapses, including poor analysis of the root causes of complaints and problems with design change review procedures.
The GMP Letter