FDA 483 - DICOM Grid, Inc. - July 27, 2022

DICOM Grid, Inc. d/b/a Ambra Health, a medical device manufacturer in New York, NY, was inspected by the FDA from July 19-27, 2022. The inspection revealed significant deficiencies in their quality system, particularly concerning recall reporting, corrective and preventive actions, risk analysis, and complaint handling for their Ambra PACS software. These issues indicate a lack of robust procedures and documentation to ensure product quality and patient safety.