# FDA 483 - Jeffrey S. Dome, M.D. - April 12, 2021

Source: https://www.keypedia.com/records/483/jeffrey-s-dome-md/155c4f90-4ad4-4b76-aa02-94676f1f2b7c

> FDA 483 for Jeffrey S. Dome, M.D. on April 12, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jeffrey S. Dome, M.D.
- Inspection Date: 2021-04-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Jeffrey S. Dome, M.D., a clinical investigator in Washington, DC, was cited with two observations during an FDA inspection. The observations relate to failures in clinical trial conduct, specifically regarding adverse event reporting and informed consent procedures. These issues indicate deficiencies in adherence to study protocols and regulatory requirements for protecting human subjects.

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Company: https://www.keypedia.com/companies/jeffrey-s-dome-md/8a2ae84e-0a68-4627-b39a-bd35baeabdba

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e