# FDA 483 - Genovefa A Papanicolaou, MD - January 27, 2021

Source: https://www.keypedia.com/records/483/genovefa-a-papanicolaou-md/ef46db40-29c5-4b00-9b2e-a4ba6db12b7f

> FDA 483 for Genovefa A Papanicolaou, MD on January 27, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genovefa A Papanicolaou, MD
- Inspection Date: 2021-01-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Genovefa Papanicolaou, M.D., Clinical Investigator in New York, NY, revealed a significant failure to maintain adequate and accurate case histories. Specifically, the investigator did not document the precise time of study drug administration for 8 out of 12 subjects, preventing a determination of protocol compliance for required electrocardiograms. This indicates serious deficiencies in clinical trial documentation practices.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/karen-l-kosar/6e58be60-f8e3-44f3-8218-8acdde249724)

Company: https://www.keypedia.com/companies/genovefa-a-papanicolaou-md/b20fcfe3-7732-49ce-a512-091733b39c7e

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