William Kulakevich: Final Debarment Order

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring William Kulakevich 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. Kulakevich was convicted of one felony count under Federal law for conspiracy to commit offenses against the United States. The factual basis supporting Mr. Kulakevich's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Kulakevich 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 September 16, 2021 (30 days after receipt of the notice), Mr. Kulakevich had not responded. Mr. Kulakevich's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.