2023-03941: Shaun Thaxter; Denial of Hearing; Final Debarment Order
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The Food and Drug Administration (FDA or the Agency) is denying a request for a hearing submitted by Shaun Thaxter (Thaxter) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Thaxter for 5 years 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 Thaxter was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Thaxter's debarment, FDA has considered the applicable factors listed in the FD&C Act. Thaxter has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
The agency’s own summary, as published.
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