Nicole Shelby Randall: Final Debarment Order

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Nicole Shelby Randall 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. Randall was convicted of one felony count under Federal law for introduction of an adulterated drug into interstate commerce. The factual basis supporting Ms. Randall's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Randall 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 July 30, 2025 (30 days after receipt of the notice), Ms. Randall had not responded. Ms. Randall'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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