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Zdrowie i gospodarka · 30.11.2020

John Kapoor: Final Debarment Order

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring John Kapoor 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 John Kapoor was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. John Kapoor was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. Mr. Kapoor, through counsel, submitted a letter to FDA, which commented on some of the factual circumstances surrounding the case. In the letter, he also stated that he did not intend to request a hearing nor, however, would he acquiesce to debarment. As of August 26, 2020 (30 days after receipt of the notice), Mr. Kapoor has not requested a hearing. His failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

Source: Federal Register — Food and Drug AdministrationOpen original release →