The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Brendon Gagne for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Gagne was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. Gagne's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Gagne was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 5, 2024 (30 days after receipt of the notice), Mr. Gagne had not responded. Mr. Gagne's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
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