Zdrowie i gospodarka · 2.08.2021
Vithal K. Patel; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Vithal K. Patel (Mr. Patel) and issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Mr. Patel for 1 year from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Patel was convicted of conspiracy to commit a felony under Federal law for conduct relating to the regulation of drug products under the FD&C Act and that the type of conduct underlying the conviction undermined the process for the regulation of drugs. In determining the appropriateness and period of Mr. Patel's debarment, FDA considered the relevant factors listed in the FD&C Act. Mr. Patel has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.