Odalys Fernandez: Debarment Order

The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Odalys Fernandez from providing services in any capacity to a person that has an approved or pending drug product application for a period of 6 years. FDA bases this order on a finding that Ms. Fernandez was convicted of five felony counts under Federal law for conduct involving health care fraud, and one count of conspiracy to commit health care fraud, and that this pattern of conduct is sufficient to find that there is reason to believe she may violate requirements under the FD&C Act relating to drug products. Ms. Fernandez was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Fernandez failed to request a hearing. Ms. Fernandez's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.