Kalpen D. Patel: Final Debarment Order

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Kalpen D. Patel 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 a felony under Federal law for conduct that relates to the regulation of any drug product under the FD&C Act. Mr. Patel was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. Mr. Patel responded to the notice by submitting correspondence to FDA, but he did not request a hearing. Mr. Patel's failure to request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.

Abstract as published in the Federal Register.

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