# FDA 483 - Robert G. Szewc MD - July 01, 2021

Source: https://www.globalkeysolutions.net/records/483/robert-g-szewc-md/7c0e46d6-ecb1-408c-8c1c-c4eab1daf51a

> FDA 483 for Robert G. Szewc MD on July 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robert G. Szewc MD
- Inspection Date: 2021-07-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: The FDA inspected Robert G. Szewc MD, a clinical investigator in San Antonio, TX, and found significant issues with clinical trial conduct. The firm failed to follow the investigational plan, resulting in incorrect dosing for multiple subjects. Additionally, serious adverse events, including three deaths, were not reported to the sponsor within the required 24-hour timeframe, and IRB reporting dates were often missing.

## Related Officers

- [Iris C. Macinnes](https://www.globalkeysolutions.net/people/iris-c-macinnes/5e8d7fef-18d5-453d-82b2-19e8e2897d26)
- [investigator](https://www.globalkeysolutions.net/people/travis-m-beard/a89f6d0b-dc5b-4adc-84f5-36e04b00fc2d)

Company: https://www.globalkeysolutions.net/companies/robert-g-szewc-md/c2ac63a1-f92b-4699-ac82-fafd6f25bca9

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab