Ildiko M. Knoll: Final Debarment Order
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ildiko M. Knoll 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 Ms. Knoll engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Ms. Knoll was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of May 29, 2023 (30 days after receipt of the notice), Ms. Knoll had not responded. Ms. Knoll's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Abstract as published in the Federal Register.
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