[Federal Register Volume 87, Number 219 (Tuesday, November 15, 2022)]
[Notices]
[Pages 68503-68504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24805]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0526]


David Elias Mendoza: 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 
David Elias Mendoza 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. Mendoza 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. Mendoza 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 28, 2022 (30 days after receipt 
of the notice), Mr. Mendoza had not responded. Mr. Mendoza's failure to 
respond and request a hearing within the timeframe prescribed by 
regulation constitutes a waiver of his right to a hearing and any 
contentions concerning this matter.

DATES: This order is applicable November 15, 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 https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of 
Enforcement (ELEM-4144), 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 
[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 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 authorized electronic data interchange system as products regulated 
by FDA.
    After an investigation, FDA discovered that Mr. Mendoza has engaged 
in numerous instances 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 were not designated in an 
authorized electronic data interchange system as products that are 
regulated by FDA; all the parcels containing the misbranded drugs 
serving as the basis for this action, described in further detail 
below, were intercepted by FDA at the John F. Kennedy (JFK) 
International Mail Facility (IMF) and were addressed to Mr. Mendoza at 
one of two addresses connected to him.
    On or about June 4, 2019, Mr. Mendoza offered for import a parcel 
that contained 250 tablets of CENFORCE-100, which was a misbranded drug 
because the product was determined to be a prescription drug product 
that failed to contain the ``Rx-only'' symbol on its label and lacked 
adequate directions for use in its labeling. The product was refused 
entry on July 9, 2019.
    On or about January 24, 2020, Mr. Mendoza offered for import a 
parcel that contained 250 tablets of CENFORCE-100, which was a 
misbranded drug because the product was determined to be a prescription 
drug product that failed to contain the ``Rx-only'' symbol on its label 
and lacked adequate directions for use in its labeling. The product was 
refused entry on February 20, 2020.
    On or about January 29, 2020, Mr. Mendoza offered for import a 
parcel that contained 250 tablets of CENFORCE-100, which was a 
misbranded drug because the product was determined to be a prescription 
drug product that failed to contain the ``Rx-only'' symbol on its label 
and lacked adequate directions for use in its labeling. The product was 
refused entry on February 25, 2020.
    On or about January 30, 2020, Mr. Mendoza offered for import a 
parcel that contained 270 tablets of CENFORCE-100, which was a 
misbranded drug because the product was determined to be a prescription 
drug product that failed to contain the ``Rx-only'' symbol on its label 
and lacked adequate directions for use in its labeling. The product was 
refused entry on February 25, 2020.
    On or about February 14, 2020, Mr. Mendoza offered for import a 
parcel that contained 330 tablets of CENFORCE-100, which was a 
misbranded drug because the product was determined to be a prescription 
drug product that failed to contain the ``Rx-only'' symbol on its label 
and lacked adequate directions for use in its labeling. The product was 
refused entry on March 17, 2020.
    On or about February 14, 2020, Mr. Mendoza offered for import a 
parcel that contained 250 tablets of CENFORCE-100, which was a 
misbranded drug because the product was determined to be a prescription 
drug product that failed to contain the ``Rx-only'' symbol on its label 
and lacked adequate directions for use in its labeling. The product was 
refused entry on March 17, 2020.
    On or about February 24, 2020, Mr. Mendoza offered for import a 
parcel that contained 250 tablets of CENFORCE-100, which was a 
misbranded drug because the product was determined to be a prescription 
drug product that failed to contain the ``Rx-only'' symbol on its label 
and lacked adequate directions for use in its labeling. The product was 
refused entry on March 19, 2020.
    On or about June 10, 2020, Mr. Mendoza offered for import a parcel 
that contained 300 tablets of CENFORCE-100, which was a misbranded drug 
because the product was determined to be a prescription drug product 
that failed to contain the ``Rx-only'' symbol on its label. The product 
was refused entry on July 10, 2020.
    On or about June 10, 2020, Mr. Mendoza offered for import a parcel 
that contained 300 tablets of CENFORCE-100, which was a misbranded drug 
because the product was determined to be a prescription drug product 
that failed to contain the ``Rx-only'' symbol on its label. The product 
was refused entry on July 7, 2020.
    On or about June 16, 2020, Mr. Mendoza offered for import a parcel 
that contained 300 tablets of CENFORCE-100, which was a misbranded drug 
because the product failed to contain adequate directions for use in 
its labeling. The product was refused entry on July 14, 2020.
    On or about June 16, 2020, Mr. Mendoza offered for import a parcel 
that contained 320 tablets of CENFORCE-100, which was a misbranded drug

[[Page 68504]]

because the product failed to contain adequate directions for use in 
its labeling. The product was refused entry on July 14, 2020.
    On or about June 18, 2020, Mr. Mendoza offered for import a parcel 
that contained 300 tablets of CENFORCE-100, which was a misbranded drug 
because the product was determined to be a prescription drug product 
that failed to contain the ``Rx-only'' symbol on its label. The product 
was refused entry on July 15, 2020.
    As a result of Mr. Mendoza's 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, FDA sent Mr. Mendoza, by certified mail on February 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. Mendoza's pattern of conduct and concluded that his 
conduct warranted the imposition of a 5-year period of debarment.
    The proposal informed Mr. Mendoza 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. Mendoza received the proposal and notice of opportunity for 
a hearing on February 26, 2022. Mr. Mendoza 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. David 
Elias Mendoza 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. Mendoza 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. Mendoza is a 
prohibited act.
    Any application by Mr. Mendoza for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2021-N-0526 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 https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500.

    Dated: November 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24805 Filed 11-14-22; 8:45 am]
BILLING CODE 4164-01-P


