FDA 483 - DICOM Grid, Inc. - September 25, 2019

An FDA inspection of DICOM GRID INC (dba) Ambra Health in New York, NY, a manufacturer of Picture Archiving and Communications Systems (PACS), identified significant deficiencies in its quality system. The firm failed to adequately establish corrective and preventive action procedures, document design verification results, and validate software used in the quality system. Additionally, design review results were not properly recorded in the design history file.