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Zdrowie i gospodarka · 05/04/2012

Jose Concepcion: Debarment Order

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Jose Concepcion 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 findings that Mr. Concepcion was convicted of conspiracy to commit an offense against the United States, that the conduct that served as the basis for the felony conspiracy conviction relates to the development or approval, including the process for development or approval, of any drug product and relates to the regulation of drug products under the FD&C Act, and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Mr. Concepcion was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Concepcion failed to request a hearing. Mr. Concepcion's 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 →