Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: Felony conviction results in FDA debarment order, (Jun 7, 2024)
By WK Editorial Staff
The respondent’s failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning the matter.
The FDA issued an order under the Federal Food, Drug, and Cosmetic Act (FDCA) debarring Marina Sievert for a period of 10 years from importing or offering for import any drug into the United States. The FDA based the order on a finding that Ms. Sievert was convicted of one felony count under Federal law for mail fraud and one felony count under Federal law for introduction of an unapproved new drug into interstate commerce. The factual basis supporting Ms. Sievert’s conviction is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Sievert 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 March 10, 2024 (30 days after receipt of the notice), Ms. Sievert had not responded (Notice, 89 Fed. Reg. 48432 (June 6, 2024)).
Dates. The order is applicable June 6, 2024.
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