90 FR 158 pgs. 40369-40370 - Doyal Kalita: Final Debarment Order
Type: NOTICEVolume: 90Number: 158Pages: 40369 - 40370
Pages: 40369, 40370Docket number: [Docket No. FDA-2025-N-0709]
FR document: [FR Doc. 2025-15787 Filed 8-18-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0709]
Doyal Kalita: Final Debarment Order
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Doyal Kalita 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. Kalita was convicted of two felony counts under Federal law. The factual basis supporting Mr. Kalita's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Kalita 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 June 26, 2025 (30 days after receipt of the notice), Mr. Kalita had not responded. Mr. Kalita's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
DATES:
This order is applicable August 19, 2025.
ADDRESSES:
Any application by Mr. Kalita 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:
Electronic Submissions
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.
• 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").
Written/Paper Submissions
• 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."
Instructions: All applications must include the Docket No. FDA-2025-N-0709. Received applications will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov 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 https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to https://www.regulations.gov 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.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
I. Background
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.
[top] On October 9, 2024, Mr. Kalita was convicted as defined in section 306(l)(1) of the FD&C Act (21 U.S.C. 335a(l)(1)), in the U.S. District Court for the District of Massachusetts, when the court accepted his plea of guilty and entered
Mr. Kalita concealed the nature of the drug sales by using merchant payment accounts for travel entities and he created fake travel records to convince the merchant account providers. Specifically, Mr. Kalita and/or his conspirators, would create fake travel itineraries for his customers who purchased his unapproved illegally imported drugs. These actions were done to cover up Mr. Kalita's and his co-conspirators illegal sales of imported misbranded drugs and controlled substances.
FDA sent Mr. Kalita, by certified mail, on May 16, 2025, a notice proposing to debar him for a 10-year period from importing or offering for import any drug into the United States. The proposal was based on a finding under section 306(b)(3)(C) of the FD&C Act that Mr. Kalita's felony conviction under Federal law for conspiracy to import Schedule II and Schedule IV controlled substances in violation of 21 U.S.C. 963 and one felony count of money laundering conspiracy in violation of 18 U.S.C. 1956(h), was for conduct relating to the importation of any drug or controlled substance into the United States because Mr. Kalita illegally imported and introduced misbranded prescription drug products and controlled substances into interstate commerce and laundered the revenues for such importation and introduction for himself and others. In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr. Kalita's offenses and concluded that the offenses warranted the imposition of a 10-year period of debarment.
The proposal informed Mr. Kalita of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Kalita received the proposal and notice of opportunity for a hearing on May 27, 2025. Mr. Kalita failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Division of Field Enforcement, Office of Inspections and Investigations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Director, Division of Enforcement, finds that Mr. Doyal Kalita has been convicted of two felonies under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offenses should be accorded a debarment period of 10 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Mr. Kalita is debarred for a period of 10 years from importing or offering for import any drug into the United States, effective (see DATES ). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Kalita is a prohibited act.
Dated: August 14, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-15787 Filed 8-18-25; 8:45 am]
BILLING CODE 4164-01-P