# FDA 483 - J. Robert Flamini - March 11, 2024

Source: https://www.keypedia.com/records/483/j-robert-flamini/d766a527-9e35-4030-94b8-042b025ecf7b

> FDA 483 for J. Robert Flamini on March 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: J. Robert Flamini
- Inspection Date: 2024-03-11
- Product Type: drugs
- Office Name: FDA District Office — Atlanta, Georgia
- Summary: An FDA inspection of J. Robert Flamini, a clinical investigator in Atlanta, GA, revealed a significant deviation from an investigational plan. Specifically, a pediatric subject in a study for partial-onset seizures was administered an incorrect dosage of the investigational product over an extended period. This indicates a failure to conduct the study in accordance with the approved protocol.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/koffi-a-amegadje/817a228e-0003-43d0-bf59-71aeba0fd1f5)

Company: https://www.keypedia.com/companies/j-robert-flamini/1ce9972f-aca1-400c-ab5e-0bd6cd8e8a4d

Office: https://www.keypedia.com/offices/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43