Notice2022-15795
Kenneth Zipperer: 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
July 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Kenneth Zipperer 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. Zipperer was convicted of one felony count under Federal law relevant to these debarment proceedings for mail fraud. The factual basis supporting Mr. Zipperer's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Zipperer 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 March 30, 2022 (30 days after receipt of the notice), Mr. Zipperer had not responded. Mr. Zipperer's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 141 (Monday, July 25, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Pages 44128-44129]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15795]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1156]
Kenneth Zipperer: 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
Kenneth Zipperer 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. Zipperer was convicted of one felony count under
Federal law relevant to these debarment proceedings for mail fraud. The
factual basis supporting Mr. Zipperer's conviction, as described below,
is conduct relating to the importation into the United States of a drug
or controlled substance. Mr. Zipperer 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 March 30, 2022 (30 days after receipt
of the notice), Mr. Zipperer had not responded. Mr. Zipperer'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 July 25, 2022.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at
<a href="/cdn-cgi/l/email-protection#0b6f6e696a79666e657f784b6d6f6a25636378256c647d"><span class="__cf_email__" data-cfemail="f296979093809f979c8681b2949693dc9a9a81dc959d84">[email protected]</span></a>.
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.
On September 9, 2021, Mr. Zipperer was convicted, as defined in
section 306(l)(1) of FD&C Act, in the U.S. District Court for the
Western District of Wisconsin, when the court entered judgment against
him for two offenses, one of which is relevant to these debarment
proceedings: the offense of mail fraud, in violation of 18 U.S.C. 1341.
FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein. The factual basis for this conviction is
as follows: Mr. Zipperer acknowledged in his plea and sentencing
hearing on September 9, 2021, that he owned and operated Zipperer
Financial LLC where he worked as an insurance broker selling Medicare
insurance policies to elderly individuals. Mr. Zipperer imported, via
U.S. mail, foreign-sourced prescription drugs from an internet pharmacy
company in India using the website ``<a href="http://www.alldaychemist.com">www.alldaychemist.com</a>.'' The
packages mailed from this pharmacy contained the return address of
Derric Wood in Delhi, India, and Mr. Zipperer had these packages
shipped to a P.O. Box he rented for Zipperer Financial LLC. Mr.
Zipperer imported many of the foreign-sourced prescription drugs in
wholesale quantities and broke down the bulk shipments and repackaged
them into retail quantities for his individual clients. Mr. Zipperer
distributed many of these foreign-sourced prescription medications to
his clients in person, though he had no valid wholesale distribution
license, pharmacy license, or license to prescribe prescription drugs.
Further, as Mr. Zipperer acknowledged in his plea and sentencing
hearing on September 9, 2021, the prescription drugs Mr. Zipperer
distributed to his clients were misbranded because they were foreign-
sourced versions of various prescription drugs that were not approved
by FDA for use in the United States and were dispensed to consumers
without a valid prescription of a practitioner licensed by law to
administer such drugs. The drugs were therefore misbranded because they
did not contain adequate directions for use. Mr. Zipperer imported
these misbranded prescription drugs in boxes containing customs
declaration forms affixed outside the box that falsely declared that
the contents were personal supply medications.
As a result of this conviction, FDA sent Mr. Zipperer, by certified
mail, on February 14, 2022, a notice proposing to debar him for a 5-
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. Zipperer's felony conviction for
mail fraud, in violation of 18 U.S.C. 1341, was for conduct relating to
the importation into the United States of any drug or controlled
substance because he illegally imported misbranded prescription drugs
and then distributed those drugs, unlawfully, to consumers. 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. Zipperer's offense and concluded that the offense warranted the
imposition of a 5-year period of debarment.
The proposal informed Mr. Zipperer 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. Zipperer received the proposal and
[[Page 44129]]
notice of opportunity for a hearing on February 28, 2022. Mr. Zipperer
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 Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Kenneth Zipperer 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, Mr. Zipperer 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 or controlled substance by,
with the assistance of, or at the direction of Mr. Zipperer is a
prohibited act.
Any application by Mr. Zipperer for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-1156 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
Publicly available submissions will be placed in the docket and
will be viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
Dated: July 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15795 Filed 7-22-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 25, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.