[Federal Register Volume 90, Number 102 (Thursday, May 29, 2025)]
[Notices]
[Pages 22741-22742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09652]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0030]
Quality Poultry and Seafood, Incorporated: 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
Quality Poultry and Seafood, Incorporated (QPS) for a period of 5 years
from importing articles of food or offering such articles for
importation into the United States. FDA bases this order on a finding
that QPS was convicted of a felony count under Federal law for conduct
relating to the importation into the United States of an article of
food. QPS was given notice of the proposed debarment and an opportunity
to request a hearing within the timeframe prescribed by regulation. As
of March 15, 2025 (30 days after receipt of the notice), QPS has not
responded. QPS' failure to respond and request a hearing constitutes a
waiver of its right to a hearing concerning this matter.
DATES: This order is applicable May 29, 2025.
ADDRESSES: Any application by QPS 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
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 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.
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
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.
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-0030. 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.
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. 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, 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, 240-402-
8743, or [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar a person, including a firm or corporation, from
importing an article of food or offering such an article for import
into the United States if FDA finds, as required by section
306(b)(3)(A) of the FD&C Act (21 U.S.C. 335a(b)(3)(A)), that the person
has been convicted of a felony for conduct relating to the importation
into the United States of any food.
On December 11, 2024, QPS was convicted as defined in section
306(l)(1)(A) of the FD&C Act in the U. S. District Court for the
Southern District of Mississippi when the court accepted its plea of
guilty and entered judgment against it for the offense of Conspiracy to
Commit Misbranding and Wire Fraud in violation of 18 U.S.C. 371.The
underlying facts supporting the conviction are as follows: As contained
in the Information, whose facts alleged therein QPS admitted to in QPS'
Plea Agreement, QPS is a Mississippi corporation operating in Biloxi as
a wholesale supplier of poultry and seafood to restaurants, casinos,
and retail markets. It also sold poultry and seafood to the general
public from its
[[Page 22742]]
retail outlet and served meals to customers at its cafe. QPS, along
with coconspirators, entered into a conspiracy to mislabel foreign
seafood and sell it as local varieties of seafood. Through QPS'
employees, QPS would purchase frozen seafood from foreign countries,
with the intent to advertise and sell the seafood as local premium
species of seafood, when in fact the fish was not local and not species
they were advertised to be. On at least one occasion, while standing in
QPS' large freezer, QPS' sales manager handed to a coconspirator,
packages of three different fish suggesting that the coconspirator
sample each and decide which would be best to substitute for the local
premium species on the conspirator's menu. On a separate occasion QPS
sold fish to a customer; QPS represented the fish to be local premium
Red Snapper but which genetic analysis determined was not Red Snapper
but was instead an imported species of lesser value. Later, one of QPS'
seafood purchasing agents notified some of QPS' other employees that
due to a shortage on snapper, QPS would be substituting triple tail for
all snapper. Triple tail was not a local fish, and QPS had in fact
imported it from South America. During a search of QPS facilities in
September 2018, two of QPS' employees, its sales manager and business
manager, made multiple false statement to FDA investigators, including,
that any mislabeling of fish by QPS was inadvertent and that if anyone
in QPS' retail market was mislabeling fish with other than its true
name, it was happening without approval. Even after the September 2018
search of QPS facilities, QPS continued selling mislabeled seafood to
customers in lieu of local varieties of seafood for at least another
year.
As a result of this conviction, FDA sent QPS, by certified mail, on
February 10, 2025, a notice proposing to debar it for a 5-year period
from importing articles of food or offering such articles for import
into the United States. The proposal was based on a finding under
section 306(b)(1)(C) of the FD&C Act that QPS' felony conviction under
Federal law for Conspiracy to Commit Misbranding and Wire Fraud in
violation of 18 U.S.C. 371, was for conduct relating to the importation
into the United States of an article of food because QPS entered into a
scheme to purchase foreign seafood which it then would either mislabel
itself and sell it directly to its retail customers or would sell it to
its retail customers in order for the retail customers to mislabel it
and sell it as local varieties of seafood 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 QPS' offense
and concluded that the offense warranted the imposition of a 5-year
period of debarment.
The proposal informed QPS of the proposed debarment and offered it
an opportunity to request a hearing, providing QPS 30 days from the
date of receipt of the letter in which to file the request, and advised
it that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. QPS received the proposal and notice of opportunity for a
hearing on February 13, 2025. QPS failed to request a hearing within
the timeframe prescribed by regulation and has, therefore, waived its
opportunity for a hearing and waived any contentions concerning its
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)(1)(C) of the FD&C
Act, under authority delegated to the Director, Division of
Enforcement, finds that QPS has been convicted of a felony under
Federal law for conduct relating to the importation into the United
States of an article of food and that it is subject to a 5-year period
of debarment.
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, QPS is debarred for a period
of 5 years from importing articles of food or offering such articles
for import 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 an article of food by,
with the assistance of, or at the direction of QPS is a prohibited act.
Dated: May 22, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09652 Filed 5-28-25; 8:45 am]
BILLING CODE 4164-01-P