# FDA 483 - Zsolt Szabo, M.D. - November 22, 2019

Source: https://www.globalkeysolutions.net/records/483/zsolt-szabo-md/b0337d80-40ac-4bb7-9bb9-0687f25221b3

> FDA 483 for Zsolt Szabo, M.D. on November 22, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zsolt Szabo, M.D.
- Inspection Date: 2019-11-22
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Zsolt Szabo, M.D., a sponsor investigator in Baltimore, MD, revealed significant deficiencies in the conduct and oversight of a clinical study. Observations included failure to adhere to protocol inclusion criteria for enrolled subjects, inadequate study monitoring, and unreported protocol deviations to the Institutional Review Board. These findings indicate a lack of proper controls in clinical trial management.

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.globalkeysolutions.net/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)

Company: https://www.globalkeysolutions.net/companies/zsolt-szabo-md/1c25b1b5-3224-45df-a498-720ad3fa3942

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