# FDA 483 - Emily A. DiMango, M.D. - August 13, 2024

Source: https://www.keypedia.com/records/483/emily-a-dimango-md/ea68244e-b31d-4367-b7cc-44dca8a883d2

> FDA 483 for Emily A. DiMango, M.D. on August 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emily A. DiMango, M.D.
- Inspection Date: 2024-08-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Columbia University Medical Center in New York revealed a significant issue regarding the prompt reporting of serious adverse events. The facility failed to adhere to protocol requirements for timely submission of SAEs to the sponsor. This indicates a lapse in clinical trial oversight and patient safety reporting procedures.

## Related Officers

- [Omadevi Somai](https://www.keypedia.com/people/omadevi-somai/8a6212bf-2dfa-44ea-bd2f-f2aeb78aa1bd)

Company: https://www.keypedia.com/companies/emily-a-dimango-md/67c89259-5c4d-4f1d-a3c9-f1ef059170e1

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