Summary:
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 Paul Zachary Lamberty for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Lamberty was convicted of two felonies under Federal law; one felony count for conspiracy and one felony count for introduction of misbranded drugs with intent to defraud and mislead. The factual basis supporting Mr. Lamberty's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Lamberty 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 8, 2025 (30 days after receipt of the notice), Mr. Lamberty had not responded. Mr. Lamberty's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.