# FDA 483 - Pedro A. Velasquez-Mieyer, M.D. - September 13, 2024

Source: https://www.keypedia.com/records/483/pedro-a-velasquez-mieyer-md/403c0e2f-75de-488f-a1e9-ab60a6633371

> FDA 483 for Pedro A. Velasquez-Mieyer, M.D. on September 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pedro A. Velasquez-Mieyer, M.D.
- Inspection Date: 2024-09-13
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: The FDA issued a Form 483 to Pedro A. Velasquez-Mieyer, M.D. in Memphis, TN, following an inspection of their clinical investigator site. The inspection revealed that an investigation was not conducted in accordance with the investigational plan. This included failures to fully assess enrollment and exclusion criteria for multiple subjects who were subsequently randomized and treated with investigational product.

## Related Officers

- [investigator](https://www.keypedia.com/people/kellie-r-riggs/556818c6-eb9a-48a5-9630-aba7a807ec07)
- [Abigail M. Cruz](https://www.keypedia.com/people/abigail-m-cruz/8dd5b407-7c2d-43a6-b070-6feed0eb9ccb)

Company: https://www.keypedia.com/companies/pedro-a-velasquez-mieyer-md/c2254c07-9850-4a23-94c0-68339dc30005

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea