United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2025_register executive 2025-09-19 article Notices D09002ee1d7a376ec D09002ee1d7a3776e United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring William Goldsmith 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. Goldsmith was convicted of one felony count under Federal law for introducing misbranded drugs into interstate commerce. The factual basis supporting Mr. Goldsmith's conviction, as described below, is conduct relating to the importation of a drug into the United States. Mr. Goldsmith 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 August 19, 2025 (more than 30 days after receipt of the notice), Mr. Goldsmith had not responded. Mr. Goldsmith's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter. 90 FR 45223 https://www.govinfo.gov/app/details/FR-2025-09-19/2025-18213 2025-18213 fr19se25-61 4164-01-P Docket No. FDA-2024-N-1873 https://www.govinfo.gov/app/details/FR-2025-09-19/2025-18213 https://www.govinfo.gov/content/pkg/FR-2025-09-19/html/2025-18213.htm https://www.govinfo.gov/content/pkg/FR-2025-09-19/pdf/2025-18213.pdf 3 p. 45223 45225 90 FR 45223 William Goldsmith: Final Debarment Order; Federal Register Vol. 90, Issue NOTICE 2025-18213 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2024-N-1873 4164-01-P 2025-18213 Notice.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring William Goldsmith 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. Goldsmith was convicted of one felony count under Federal law for introducing misbranded drugs into interstate commerce. The factual basis supporting Mr. Goldsmith's conviction, as described below, is conduct relating to the importation of a drug into the United States. Mr. Goldsmith 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 August 19, 2025 (more than 30 days after receipt of the notice), Mr. Goldsmith had not responded. Mr. Goldsmith's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

This order is applicable September 19, 2025. Jaime Espinosa, Division of Field Enforcement, Office of Field Regulatory Operations, Office of Inspections and Investigations, Food and Drug Administration, 240-402- 8743, or debarments@fda.hhs.gov. Final Debarment Order William Goldsmith, debarments@fda.hhs.gov https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 90, no. 180 Office of the Federal Register, National Archives and Records Administration 2025-09-19 continuing daily deposited born digital 206 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2025-09-19 P0b002ee1d7a16ec5 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19se25 https://www.govinfo.gov/app/details/FR-2025-09-19 https://www.govinfo.gov/content/pkg/FR-2025-09-19/pdf/FR-2025-09-19.pdf https://www.govinfo.gov/content/pkg/FR-2025-09-19/xml/FR-2025-09-19.xml fdlp 45117 45312 DGPO 2025-09-19 2025-09-19 FR-2025-09-19 machine generated eng FR FR-2025-09-19 90 180