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

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.