# FDA 483 - Roger S. Keresztes, M.D. - September 27, 2019

Source: https://www.keypedia.com/records/483/roger-s-keresztes-md/3b80e05b-f5da-4262-8b5c-ed5352368389

> FDA 483 for Roger S. Keresztes, M.D. on September 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roger S. Keresztes, M.D.
- Inspection Date: 2019-09-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Roger S. Keresztes, M.D. in Stony Brook, NY, a clinical investigator, revealed significant deviations from good clinical practice. The firm failed to conduct investigations in accordance with the investigational plan, enrolling subjects who did not meet eligibility criteria or lacked required pre-enrollment testing. Additionally, the inspection found failures in obtaining informed consent prior to study procedures and maintaining complete case histories, indicating serious issues with human subject protection and data integrity.

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## Related Officers

- [investigator](https://www.keypedia.com/people/yvette-m-lacour-davis/8bae7c3f-2c46-4bf0-9e77-beaa25cdad91)

Company: https://www.keypedia.com/companies/roger-s-keresztes-md/54869ce0-0f14-4703-99c0-6ce30ef2ac9e

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