DICOM Grid, Inc.September 25, 2019

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

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Record Details

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.

Company: DICOM Grid, Inc.
Inspection Date: September 25, 2019
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Jacqueline S. Warner

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ID · e2519b95-d54c-43c4-a02b-e4b3b30410c8