[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12381-12384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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

[[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 https://www.regulations.gov.
    [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 https://www.regulations.gov 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 https://www.regulations.gov. 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: 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. 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 [email protected].

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


