2023-03958: Wojciech Lesniak: Final Debarment Order
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The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Wojciech Lesniak 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. Lesniak engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with his personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Mr. Lesniak 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 November 21, 2022 (30 days after receipt of the notice), Mr. Lesniak had not responded. Mr. Lesniak's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
The agency’s own summary, as published.
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