Harpreet Singh: Final Debarment Order

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-N-3359]</DEPDOC> <SUBJECT>Harpreet Singh: Final Debarment Order</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Harpreet Singh 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 Mr. Singh was convicted of multiple felony offenses, which serve as the basis for this debarment, that are conspiracy to possess with intent to distribute cathinone, tapentadol, tramadol, and carisoprodol; one felony count under Federal law for fraudulent importation and transportation of goods; one felony count under Federal law for conspiracy to launder money; and one felony count under Federal law for conspiracy to obstruct justice. The factual basis supporting Mr. Singh's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Singh 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 November 20, 2024 (30 days after receipt of the notice), Mr. Singh had not responded. Mr. Singh's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> This order is applicable March 13, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> Any application by Mr. Singh for termination of debarment under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be submitted at any time as follows: <HD SOURCE="HD2">Electronic Submissions</HD> • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov</E> . Follow the instructions for submitting comments. An application submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your application will be made public, you are solely responsible for ensuring that your application does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your application, that information will be posted on <E T="03">https://www.regulations.gov</E> . • If you want to submit an application with confidential information that you do not wish to be made available to the public, submit the application as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For a written/paper application submitted to the Dockets Management Staff, FDA will post your application, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All applications must include the Docket No. FDA-2024-N-3359. Received applications will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit an application with confidential information that you do not wish to be made publicly available, submit your application only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of your application. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov</E> . Submit both copies to the Dockets Management Staff. Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</E> . <E T="03">Docket:</E> For access to the docket, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Publicly available submissions may be seen in the docket. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Jaime Espinosa, Division of Field Enforcement, Office of Field Regulatory Operations, Office of Inspections and Investigations, Food and Drug Administration, at 240-402-8743, or <E T="03">debarments@fda.hhs.gov</E> . </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D)) permits debarment of an individual from importing or offering for import any drug into the United States if FDA finds, as required by section 306(b)(3)(C) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance. On May 21, 2024, Mr. Singh was convicted as defined in section 306(l)(1) of the FD&C Act in the United States District Court for the Eastern District of New York when the court accepted his plea of guilty and entered judgment against him for multiple felony offenses that are conspiracy to possess with intent to distribute cathinone, tapentadol, tramadol, and carisoprodol, in violation of 21 U.S.C. 846 and 841(b)(1)(C); one felony count under Federal law for fraudulent importation and transportation of goods in violation of 18 U.S.C. 545; one felony count under Federal law for conspiracy to launder money in violation of 18 U.S.C. 1956(a) and 1956(h); and one felony count under Federal law for conspiracy to obstruct justice in violation of 18 U.S.C. 1512(c) and 1512(k). The underlying facts supporting the conviction are as follows: as contained in the Information from his case, between January 2017 and September 2019, Mr. Singh knowingly, intentionally and with intent to defraud the United States, smuggled, and clandestinely introduced and attempted to smuggle and clandestinely introduced into the United States misbranded drugs, which should had been invoiced, and made out and passed, and attempted to pass, through the customhouse one or more false, forged and fraudulent invoices, and other documents and papers; and knowingly, intentionally and fraudulently imported and brought into the United States merchandise contrary to law, and receive, conceal, buy, sell and facilitate the transportation, concealment and sale of the misbranded drugs, knowing that the drugs to have been imported and brought into the United States contrary to law. In addition, Mr. Singh together with others, did knowingly and intentionally conspire to distribute and possess with intent to distribute one or more controlled substances that are cathinone, a schedule I controlled substance; tapentadol, a schedule II controlled substance; and tramadol and carisoprodol, schedule IV controlled substances. Also, together with others, Mr. Singh knowingly and intentionally conspired: (a) to conduct one or more financial transactions affecting interstate and foreign commerce, to wit: interstate and foreign transfers of funds and payments of Federal Express bills, which transactions in fact involved the proceeds of specified unlawful activity, to wit: the crimes charged in counts one and two of the Information, knowing that the property involved in the financial transactions represented the proceeds of some form of unlawful activity, with the intent to promote the carrying on of specified unlawful activity, in violation of 18 U.S.C. 1956(a)(1)(A)(i); and (b) to conduct one or more financial transactions affecting interstate and foreign commerce, to wit: interstate and foreign transfers of funds and payments of Federal Express bills, which transactions in fact involved the proceeds of the crimes charged in counts one and two of the Information, knowing that the property involved in the financial transactions represented the proceeds of some form of unlawful activity, and knowing that the transactions were designed in whole and in part to conceal and disguise the nature, location, source, ownership and control of the proceeds of specified unlawful activity, in violation of 18 U.S.C. 1956(a)(1)(B)(i). As further contained in the Information from Mr. Singh's case, between approximately August 2019 and September 2019, Mr. Singh, together with others, knowingly and intentionally conspired to corruptly alter, destroy, mutilate and conceal records, documents and other objects with the intent to impair the objects' integrity and availability for use in an official proceeding, to ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 13k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━