# FDA 483 - Amanda L. Cox, MD - May 10, 2024

Source: https://www.keypedia.com/records/483/amanda-l-cox-md/a2e7ceae-7ee5-40ea-8852-f6711bf43a70

> FDA 483 for Amanda L. Cox, MD on May 10, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amanda L. Cox, MD
- Inspection Date: 2024-05-10
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Mount Sinai Kravis Children's Hospital identified a significant issue in a clinical investigation involving children. The principal investigator failed to consistently obtain permission from both parents for enrolled subjects, which is a requirement per institutional review board approval and for the COVID-19 addendum to informed consent forms. This indicates a critical lapse in ensuring proper informed consent for pediatric participants.

## Related Officers

- [Lucilla Facchin](https://www.keypedia.com/people/lucilla-facchin/e5c5c863-b2f4-44a8-8093-d1cb4f71949b)

Company: https://www.keypedia.com/companies/amanda-l-cox-md/151253dc-b24f-44a2-a9cc-86ef639db809

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