# FDA 483 - Tyrone McCall, M.D. - September 19, 2022

Source: https://www.globalkeysolutions.net/records/483/tyrone-mccall-md/b3d18006-fde6-4e08-8135-998c83d12508

> FDA 483 for Tyrone McCall, M.D. on September 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tyrone McCall, M.D.
- Inspection Date: 2022-09-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Tyrone McCall, M.D. in Dallas, TX, a clinical investigator, revealed a significant regulatory violation. The firm failed to submit an Investigational New Drug (IND) application to the FDA before conducting a clinical investigation. This unapproved study involved enrolling, randomizing, and treating sixty-nine subjects with an investigational new drug.

## Related Officers

- [Joanne M. Schlossin](https://www.globalkeysolutions.net/people/joanne-m-schlossin/5cb48b8a-d885-4b4f-8c60-d4714d65603d)

Company: https://www.globalkeysolutions.net/companies/tyrone-mccall-md/50c2a5c5-3c1a-4d31-9962-c8c2d6f5c50b

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