Notice2026-03254
Sherri Insprucker: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 19, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 Sherri Insprucker 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 Ms. Insprucker was convicted of one felony count under Federal law for conspiracy to introduce a misbranded drug in interstate commerce with the intent to defraud and mislead. The factual basis supporting Ms. Insprucker's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Insprucker was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of June 16, 2025 (30 days after receipt of the notice), Ms. Insprucker had not responded. Ms. Insprucker's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 91 Issue 33 (Thursday, February 19, 2026)</title>
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[Federal Register Volume 91, Number 33 (Thursday, February 19, 2026)]
[Notices]
[Pages 8001-8003]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03254]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0342]
Sherri Insprucker: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 Sherri Insprucker 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 Ms. Insprucker was convicted of one felony
count under Federal law for conspiracy to introduce a misbranded drug
in interstate commerce with the intent to defraud and mislead. The
factual basis supporting Ms. Insprucker's conviction, as described
below, is conduct relating to the importation into the United States of
a drug or controlled substance. Ms. Insprucker was given notice of the
proposed debarment and was given an opportunity to request a hearing to
show why she should not be debarred. As of June 16, 2025 (30 days after
receipt of the notice), Ms. Insprucker had not responded. Ms.
Insprucker's failure to respond and request a hearing constitutes a
waiver of her right to a hearing concerning this matter.
DATES: This order is applicable February 19, 2026.
ADDRESSES: Any application by Ms. Insprucker 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
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
[[Page 8002]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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
<bullet> 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.
<bullet> 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-0342. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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, at 240-
402-8743, or <a href="/cdn-cgi/l/email-protection#9afefff8fbe8f7fff4eee9dafcfefbb4f2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="65010007041708000b1116250301044b0d0d164b020a13">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act 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 December 5, 2024, Ms. Insprucker was convicted as defined in
section 306(l)(1) of the FD&C Act, in the U.S. District Court for the
Western District of Texas-San Antonio Division, when the court accepted
her plea of guilty and entered judgment against her for the felony
offense of conspiracy to introduce a misbranded drug in interstate
commerce with the intent to defraud and mislead in violation of 18
U.S.C. 371 and 21 U.S.C. 331(a), 333(a)(2), 352(a)(1), 353(b)(1), and
352(f) (sections 301(a), 303(a)(2), 502(a)(1), 503(b)(1), and 502(f))
of the FD&C Act). The underlying facts supporting the conviction are as
follows:
As contained in the Information, and in the Plea Agreement from her
case, in or about December 2022 Ms. Insprucker responded to an online
posting from a person referred in court documents as Individual #1. Ms.
Insprucker agreed, along with Justin Insprucker, to receive parcel
shipments sent in interstate commerce to her residence that Ms.
Insprucker would repackage and ship to individuals and businesses
throughout the United States for pay. Ms. Insprucker opened a Post
Office (P.O.) Box at a U.S. Postal Service (USPS) location under the
name American Wellness LLC. Ms. Insprucker and Justin Insprucker
received packages of misbranded sildenafil and tadalafil delivered to
the P.O. Box and/or the Insprucker residence. Ms. Insprucker repackaged
these drugs and shipped them to other individuals and businesses in
interstate commerce.
An FDA Office of Criminal Investigations (OCI) investigation
revealed that from December 2022 through at least October 2023,
multiple notices of FDA Seizures were issued to Ms. Insprucker's and
Justin Insprucker's residence and to the American Wellness LLC P.O. Box
for parcels containing misbranded sildenafil and tadalafil shipped in
interstate commerce and destined for Ms. Insprucker and Justin
Insprucker's residence and/or P.O. Box. The notices of FDA action
informed Ms. Insprucker that the products seized were prescription
drugs and that the individual boxes inside the parcels did not contain
the ``Rx only'' required description on its label. In September and
October 2023, law enforcement seized additional parcels containing
misbranded sildenafil and tadalafil that were shipped in interstate
commerce and destined for Ms. Insprucker and Justin Insprucker's
residence and/or P.O. Box. OCI's investigation also revealed that Ms.
Insprucker and Justin Insprucker repackaged bulk quantities of the
misbranded drugs containing sildenafil and tadalafil in packaging that
failed to disclose the drugs contained sildenafil and tadalafil and
that falsely claimed the drugs were manufactured in the United States
and contained herbal supplements. After repackaging the misbranded
drugs, Ms. Insprucker and Justin Insprucker shipped the packages via
USPS and other commercial carriers to individuals and businesses
located throughout the United States. On November 3, 2023, OCI agents
executed a search warrant at Ms. Insprucker's residence. Ms.
Insprucker's residence contained a room with several large parcels
containing misbranded sildenafil and tadalafil and unused USPS boxes to
be used for repackaging the items for delivery. During an interview
with agents, Ms. Insprucker admitted that she received shipments of
misbranded sildenafil and tadalafil that came from overseas and/or out
of state which Ms. Insprucker would repackage and ship to customers in
interstate commerce. Ms. Insprucker told investigators that she knew
the drugs she was receiving require a prescription. Finally, Ms.
Insprucker told investigators that she recruited another person to
receive parcels containing misbranded sildenafil and tadalafil and to
also repack and reship the drugs to other locations.
FDA sent Ms. Insprucker, by certified mail, on May 9, 2025, a
notice proposing to debar her for a 5-year period from importing or
offering for
[[Page 8003]]
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 Ms.
Insprucker's felony conviction under federal law for conspiracy to
introduce a misbranded drug in interstate commerce with the intent to
defraud and mislead in violation of 18 U.S.C. 371 and 21 U.S.C. 331(a),
333(a)(2), 352(a)(1), 353(b)(1), and 352(f), was for conduct relating
to the importation of any drug or controlled substance into the United
States because Ms. Insprucker illegally received foreign unapproved
prescription drugs which she repackaged and sent out to consumers
throughout the U.S. In proposing a debarment period, FDA weighed the
considerations set forth in section 306(c)(3) of the FD&C Act that the
Agency considered applicable to Ms. Insprucker's offense and concluded
that the offense warranted the imposition of a 5-year period of
debarment.
The proposal informed Ms. Insprucker of the proposed debarment and
offered her an opportunity to request a hearing, providing her 30 days
from the date of receipt of the letter in which to file the request,
and advised her that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Ms. Insprucker received the proposal and notice of opportunity
for a hearing on May 16, 2025. Ms. Insprucker failed to request a
hearing within the timeframe prescribed by regulation and has,
therefore, waived her opportunity for a hearing and waived any
contentions concerning her debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Division of Field Enforcement Director, 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 Ms. Sherri Insprucker has been convicted of a
felony under federal law for conduct relating to the importation into
the United States of any drug or controlled substance. FDA finds that
the offense should be accorded a debarment period of 5 years as
provided by section 306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Ms. Insprucker is debarred
for a period of 5 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 Ms. Insprucker is a prohibited act.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03254 Filed 2-18-26; 8:45 am]
BILLING CODE 4164-01-P
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