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Zdrowie i gospodarka · 17/02/2017

Karis Copper Delong: Debarment Order

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Karis Copper Delong for a period of 12 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 Ms. Delong was convicted of four misdemeanor counts under the FD&C Act for introducing, delivering for introduction, and causing the introduction and delivery for introduction of a misbranded drug into interstate commerce, which relates to the regulation of drug products under the FD&C Act. In addition, FDA determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Ms. Delong was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Delong failed to request a hearing. Ms. Delong's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.

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