Notice2023-03958
Wojciech Lesniak: Final Debarment Order
Primary source
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Published
February 27, 2023
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 Wojciech Lesniak 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. Lesniak engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with his personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Mr. Lesniak 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 21, 2022 (30 days after receipt of the notice), Mr. Lesniak had not responded. Mr. Lesniak's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 88 Issue 38 (Monday, February 27, 2023)</title>
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[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12381-12384]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03958]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1046]
Wojciech Lesniak: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Wojciech Lesniak 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. Lesniak engaged in a pattern of importing or offering
for import misbranded drugs (i.e., in an amount, frequency, or dosage
that is inconsistent with his personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. Mr. Lesniak 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 21, 2022 (30 days after
receipt of the notice), Mr. Lesniak had not responded. Mr. Lesniak'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 February 27, 2023.
ADDRESSES: Any application by Mr. Lesniak for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be
submitted as follows:
Electronic Submissions
[ssquf] 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
[[Page 12382]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
[ssquf] 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
[ssquf] 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.
[ssquf] 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-
2022-N-1046. 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.
[ssquf] 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. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your application and you must identify this
information as ``confidential.'' 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. Publicly
available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa (ELEM-4144), Division
of Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 240-402-
8743, or <a href="/cdn-cgi/l/email-protection#b6d2d3d4d7c4dbd3d8c2c5f6d0d2d798dedec598d1d9c0"><span class="__cf_email__" data-cfemail="c8acadaaa9baa5ada6bcbb88aeaca9e6a0a0bbe6afa7be">[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 the FDA finds, as required by
section 306(b)(3)(D) of the FD&C Act, that the individual has engaged
in a pattern of importing or offering for import misbranded drugs (i.e.
in an amount, frequency, or dosage that is inconsistent with personal
or household use by the importer), that are not designated in an entry
in an authorized electronic data interchange system as products
regulated by FDA.
After an investigation, FDA discovered that Mr. Lesniak has engaged
in numerous instances of importing or offering for import misbranded
drugs; all the parcels containing the misbranded drugs serving as the
basis for this action, described in further detail below, were
intercepted by FDA at either the Miami or the Newark International Mail
Facilities (IMF) and were addressed to Mr. Lesniak at an address
connected to him.
On or about June 28, 2019, Mr. Lesniak offered for import a parcel
intercepted and processed by FDA at the Newark IMF and which was
addressed to him. This parcel contained multiple products. FDA
determined that one of the products contained in this parcel was 280
tablets of BAYER ASPIRIN C (Acidum acetylsalicylicum 400 milligram (mg)
+ Acidum Ascorbicum 240 mg) and was refused entry on August 15, 2019,
because the product's required label or labeling appeared to not be in
English, in violation of 21 CFR. 201.15(c)(1). FDA also determined that
another product contained in this parcel was 360 tablets of APAP
(paracetamolum 500 mg) tabletki powlekane. The product was refused
entry on August 15, 2019, because the product's required label or
labeling appeared to not be in English, in violation of 21 CFR.
201.15(c)(1). FDA also determined that another product contained in
this parcel was 300 tablets of APAP EXTRA (Paracetamolum 500 mg +
Caffeinum 65 mg). The product was refused entry on August 15, 2019,
because the product's required label or labeling appeared to not be in
English, in violation of 21 CFR 201.15(c)(1). The product was a
misbranded drug pursuant to section 502(c) of the FD&C Act. FDA also
determined that another product contained in this parcel was 156
tablets of ALTACET TABLETKI (Aluminii Acetas Tartas 1 gram (g)). The
product was refused entry on August 15, 2019, because the product's
required label or labeling appeared to not be in English, in violation
of 21 CFR 201.15(c)(1). All the products in this parcel were misbranded
drugs pursuant to section 502(c) of the FD&C Act.
On or about July 02, 2019, Mr. Lesniak offered for import a parcel
intercepted and processed by FDA at the Newark IMF and which was
addressed to him. This parcel contained multiple products. The FDA
determined that one of the products contained in this parcel was 600 g
of MASC CYNKOWA (Zinc Oxidi urguentum) 10%. The product was refused
entry on August 22, 2019, because the product's required label or
labeling appeared to not be in English, in violation of 21 CFR
201.15(c)(1), and because the product appeared to be an over-the-
counter drug without required labeling. FDA determined that one of the
products contained in this parcel was 960 tablets of NO-SPA
(Drotaverini hydrochloridum 40 mg). The product was refused entry on
August 22, 2019, because the product's required label or labeling
appeared to not be in English, in violation of 21 CFR 201.15(c)(1), and
because the product appeared to be an over-the-counter drug without
required labeling. FDA determined that one of the products contained in
this parcel was 80 tablets of RANIGAST MAX (Ranitidinum 150 mg). The
product was refused entry on August 22, 2019, because the product's
required label or labeling appeared to not be in English, in violation
of 21 CFR 201.15(c)(1), and because the product appeared to be an over-
the-counter drug without required labeling. FDA determined that one of
the products contained in this parcel was 3 packages of OROFAR TOTAL
[[Page 12383]]
ACTION (Benzoxonii chloridum + Lidocaini Hydrochloridum (2.5 mg + 1,5
mg/milliliters (ml))). The product was refused entry on August 22,
2019, because the product's required label or labeling appeared to not
be in English, in violation of 21 CFR 201.15(c)(1), and because the
product appeared to be an over-the-counter drug without required
labeling. FDA determined that one of the products contained in this
parcel was 10 packages of MASC ICHTIOLOWA (Ammonii Bituminosulfonatis
Unguentum FP 10%). The product was refused entry on August 22, 2019,
because the product's required label or labeling appeared to not be in
English, in violation of 21 CFR 201.15(c)(1), and because the product
appeared to be an over-the-counter drug without required labeling. All
of the products in this parcel were misbranded drugs pursuant to
section 502(c) of the FD&C Act.
On or about July 02, 2019, Mr. Lesniak offered for import another
parcel intercepted and processed by the FDA at the Newark IMF and which
was addressed to him. FDA determined that one of the products contained
in this parcel was 530 tablets of RANIGAST MAX (Ranitidinum 150mg). The
product was refused entry on August 23, 2019, because the product's
required label or labeling appeared to not be in English, in violation
of 21 CFR 201.15(c)(1). FDA determined that one of the products
contained in this parcel was 25 packages of LIOTON 1000 ZEL (Heparinum
Natricum). The product was refused entry on August 23, 2019, because
the product's required label or labeling appeared to not be in English,
in violation of 21 CFR 201.15(c)(1). FDA determined that one of the
products contained in this parcel was 10 packages of MASC ICHTIOLOWA
(Ammonii bituminosulfonatis unguentum FP). The product was refused
entry on August 23, 2019, because the product's required label or
labeling appeared to not be in English, in violation of 21 CFR
201.15(c)(1). FDA determined that one of the products contained in this
parcel was 20 packages of OPOKAN ACTIGEL (100mg/ml, zel Naproxenum).
The product was refused entry on August 23, 2019, because the product's
required label or labeling appeared to not be in English, in violation
of 21 CFR 201.15(c)(1). FDA determined that one of the products
contained in this parcel was 3 packages of ALTACEL ZEL (Aluminii
Acetotartras 10mg/g). The product was refused entry on August 23, 2019,
because the product's required label or labeling appeared to not be in
English, in violation of 21 CFR 201.15(c)(1). All the products in this
parcel were misbranded drugs pursuant to section 502(c) of the FD&C
Act.
On or about January 4, 2022, Mr. Lesniak offered for import another
parcel intercepted and processed by FDA at the Miami IMF and which was
addressed to him. FDA determined that one of the products contained in
this parcel was 4 boxes of DIOHESPAN MAX and was a misbranded drug
pursuant to section 502(c) of the FD&C Act because the product's
required label or labeling was not in English in violation of 21 CFR
201.15(c)(1) and the drug was not included in a list required by
section 510(j) of the FD&C Act. FDA determined that another one of the
products contained in this parcel was 4 boxes of NEO-ANGIN and was a
misbranded drug pursuant to section 502(c) of the FD&C Act because the
product's required label or labeling was not in English, in violation
of 21 CFR 201.15(c)(1), and the drug was not included in a list
required by section 510(j) of the FD&C Act. FDA determined that another
one of the products contained in this parcel was 10 boxes of FURAGINUM
and was a misbranded drug pursuant to section 502(c) of the FD&C Act
because the product's required label or labeling was not in English, in
violation of 21 CFR 201.15(c)(1), and the drug was not included in a
list required by section 510(j) of the FD&C Act. FDA determined that
another one of the products contained in this parcel was 10 boxes of
ALTACET and was a misbranded drug pursuant to section 502(c) of the
FD&C Act because the product's required label or labeling was not in
English, in violation of 21 CFR 201.15(c)(1), and the drug was not
included in a list required by section 510(j) of the FD&C Act. FDA
determined that another one of the products contained in this parcel
was 17 boxes of RUTINOSCORBIN and was a misbranded drug pursuant to
section 502(c) of the FD&C Act because the product's required label or
labeling was not in English, in violation of 21 CFR 201.15(c)(1), and
it was determined the drug is not included in a list required by
section 510(j) of the FD&C Act. FDA determined that another one of the
products contained in this parcel was 10 boxes of ESPUMISAN MAX and was
a misbranded drug pursuant to section 502(c) of the FD&C Act because
the product's required label or labeling was not in English, in
violation of 21 CFR 201.15(c)(1), and it was determined the drug is not
included in a list required by section 510(j) of the FD&C Act. FDA
determined that another one of the products contained in this parcel
was 18 boxes of RAPHACHOLIN FORTE and was a misbranded drug pursuant to
section 502(c) of the FD&C Act because the product's required label or
labeling was not in English, in violation of 21 CFR 201.15(c)(1), and
it was determined the drug is not included in a list required by
section 510(j) of the FD&C Act. FDA determined that another one of the
products contained in this parcel was 20 boxes of WEGIEL LECZNICZY and
was a misbranded drug pursuant to section 502(c) of the FD&C Act
because the product's required label or labeling was not in English, in
violation of 21 CFR 201.15(c)(1), and it was determined the drug is not
included in a list required by section 510(j) of the FD&C Act. FDA
determined that another one of the products contained in this parcel
was 41 boxes of GRIPEX MAX and was a misbranded drug pursuant to
section 502(c) of the FD&C Act because the product's required label or
labeling was not in English, in violation of 21 CFR 201.15(c)(1), and
it was determined the drug was not included in a list required by
section 510(j) of the FD&C Act. All the products in this parcel were
destroyed on March 11, 2022.
On or about February 16, 2022, Mr. Lesniak offered for import a
parcel intercepted and processed by the FDA at the Miami IMF and which
was addressed to him. FDA determined that the product contained in this
parcel was 42 boxes of FLEGAMINA CLASSIC and was a misbranded drug
pursuant to section 502(c) of the FD&C Act because the product's
required label or labeling was not in English, in violation of 21 CFR
201.15(c)(1). The product was destroyed on March 11, 2022.
On or about February 16, 2022, Mr. Lesniak offered for import
another parcel intercepted and processed by the FDA at the Miami IMF
and which was addressed to him. FDA determined that the product
contained in this parcel was 42 boxes of FLEGAMINA CLASSIC and was a
misbranded drug pursuant to section 502(c) of the FD&C Act because the
product's required label or labeling was not in English, in violation
of 21 CFR 201.15(c)(1). The product was destroyed on March 11, 2022.
On or about February 18, 2022, Mr. Lesniak offered for import a
parcel intercepted and processed by the FDA at the Miami IMF and which
was addressed to him. FDA determined that the product contained in this
parcel was 42 boxes of FLEGAMINA CLASSIC and was a misbranded drug
pursuant to section 502(c) of the FD&C Act because the product's
required label or labeling was not in English, in violation of 21 CFR
201.15(c)(1), and it was determined
[[Page 12384]]
the drug was not included in a list required by section 510(j) of the
FD&C Act. The product was refused entry on March 22, 2022.
As a result of this pattern of importing or offering for import
misbranded drugs (i.e. in an amount, frequency, or dosage that is
inconsistent with his personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA, in accordance with section 306(b)(3)(D) of
the FD&C Act (21 U.S.C. 335a(b)(3)(D)), FDA sent Mr. Lesniak, by
certified mail on October 17, 2022, a notice proposing to debar him for
a 5-year period from importing or offering for import any drug into the
United States. 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. Lesniak's pattern of conduct and concluded
that his conduct warranted the imposition of a five-year period of
debarment. The proposal informed Mr. Lesniak of the proposed debarment
and offered him an opportunity to request a hearing, providing 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. Lesniak received the proposal and notice of opportunity for
a hearing on October 22, 2022. Mr. Lesniak 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)(D) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Wojciech Lesniak has engaged in a pattern of importing or offering for
import misbranded drugs (i.e. in an amount, frequency, or dosage that
is inconsistent with his personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. FDA finds that this pattern of conduct
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. Lesniak 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 Mr. Lesniak is a prohibited act.
Dated: February 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03958 Filed 2-24-23; 8:45 am]
BILLING CODE 4164-01-P
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