Zdrowie i gospodarka · 10.02.2022
Brenda K. Marmas: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Brenda K. Marmas 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. Marmas engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with her personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Ms. Marmas 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 December 12, 2021 (30 days after receipt of the notice), Ms. Marmas had not responded. Ms. Marmas' failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.