FDAnews Device Daily Bulletin

Telemetry firm ScottCare has corrected all violations found during a site inspection earlier this year, earning an Aug. 13 close out letter from the FDA’s Cincinnati District Office. “Based on our evaluation, 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.
Devices & Diagnostics Letter