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

Source: https://www.keypedia.com/records/483/dicom-grid-inc/5b8da0b3-55f3-46ec-a0db-aa56c4f11650

> FDA 483 for DICOM Grid, Inc. on July 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DICOM Grid, Inc.
- Inspection Date: 2022-07-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Documents

- [483 - 2019-09-25](https://www.keypedia.com/records/483/dicom-grid-inc/e2519b95-d54c-43c4-a02b-e4b3b30410c8)

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/dicom-grid-inc/34d135c7-cff2-47a6-9ab5-e09d304cf799

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961