Document ID: FDA-2011-N-0589-0001
Agency: fda
Document Type: Rule
Title: Anneri Izurieta: Debarment Orders:
Posted Date: 2012-01-13T05:00Z

[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2070-2071]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-542]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0589]

Anneri Izurieta: 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 (the FD&C Act) debarring 
Anneri Izurieta for a period of 30 years from importing articles of 
food or offering such articles for importation into the United States. 
FDA bases this order on a finding that Ms. Izurieta was convicted of 
six felony counts under Federal law for conduct relating to the 
importation into the United States of an article of food. Ms. Izurieta 
was given notice of the proposed debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. As of 
November 4, 2011 (30 days after receipt of the notice), Ms. Izurieta 
had not responded. Ms. Izurieta's failure to respond constitutes a 
waiver of her right to a hearing concerning this action.

DATES: This order is effective January 13, 2012.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Kenny Shade, Office of Regulatory Affairs, Food and Drug 
Administration, 12420 Parklawn Dr., Rockville, MD 20857, (301) 796-
4640.

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 an individual 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, that the 
individual has been convicted of a felony for conduct relating to the 
importation into the United States of any food.
    On May 11, 2011, in the U.S. District Court for the Southern 
District of Florida, Ms. Izurieta was convicted of one count of 
conspiracy to smuggle goods into the United States, in violation of 18 
U.S.C. 371, and five counts of smuggling goods into the United States, 
in violation of 18 U.S.C. 545. The U.S. District Court for the Southern 
District of Florida entered judgment against Ms. Izurieta on July 29, 
2011.
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein for conduct relating to the importation 
into the United States of any food. The factual basis for these 
convictions is as follows: On or about April 18, 2007, and continuing 
through on or about December 23, 2010, in violation of 18 U.S.C. 371, 
Ms. Izurieta knowingly, and with the intent to further the object of 
the conspiracy, conspired with others to commit an offense against the 
United States to fraudulently and knowingly import and bring into the 
United States merchandise contrary to law in violation of 18 U.S.C. 
545. Specifically, Ms. Izurieta conspired to distribute and sell 
imported dairy products that FDA had detained after receiving notice 
from FDA that the dairy products were suspected to be adulterated.
    While serving as president and director of Naver Trading, Ms. 
Izurieta caused dairy products and other food to be imported from 
Honduras and Nicaragua. Despite a request from FDA to disclose the 
location of shipments of dairy products after learning that FDA had 
slated specific shipments for examination due to concerns of 
adulteration with Escherichia coli,

[[Page 2071]]

Staphylococcus aureus, and Salmonella, Ms. Izurieta failed to do so. 
Ms. Izurieta also distributed shipments of dairy products after 
learning that FDA had slated specific shipments for examination due to 
concerns of adulteration with E. coli, S. aureus, and Salmonella. Ms. 
Izurieta failed to redeliver for destruction and exportation shipments 
of dairy products that FDA had determined to be adulterated with E. 
coli, S. aureus, and Salmonella and that were not authorized for entry 
into the United States. Ms. Izurieta then distributed dairy products 
that were adulterated and not authorized for entry into the United 
States. This conduct was in violation of 18 U.S.C. 545.
    From approximately April 18, 2007, and continuing to approximately 
December 7, 2010, Ms. Izurieta fraudulently and knowingly imported and 
brought into the United States merchandise contrary to law. Further, 
Ms. Izurieta failed to redeliver, export, and destroy with FDA 
supervision the dairy products and other food products contained in 
these shipments after receiving notice from FDA regarding concerns 
about the adulteration of these products with E. coli, S. aureus, and/
or Salmonella.
    As a result of her conviction, on September 28, 2011, FDA sent Ms. 
Izurieta a notice by certified mail proposing to debar her for a period 
of 30 years 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 Ms. Izurieta was 
convicted of six felony counts under Federal law for conduct relating 
to the importation into the United States of an article of food because 
she conspired to and did commit offenses related to the importation of 
dairy products and other products into the United States, and a 
determination, after consideration of the factors set forth in section 
306(c)(3) of the FD&C Act that Ms. Izurieta should be subject to the 
maximum possible period of debarment. The proposal also offered Ms. 
Izurieta an opportunity to request a hearing, providing her 30 days 
from the date of receipt of the letter in which to file the request, 
and advised her that failure to request a hearing constituted a waiver 
of the opportunity for a hearing and of any contentions concerning this 
action. Ms. Izurieta failed to respond within the timeframe prescribed 
by regulation and has, therefore, waived her opportunity for a hearing 
and waived any contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(b)(1)(C) of the FD&C Act, and 
under authority delegated to the Director (Staff Manual Guide 1410.35), 
finds that Ms. Anneri Izurieta has been convicted of six felony counts 
under Federal law for conduct relating to the importation of an article 
of food into the United States and that she is subject to the full 
period of debarment.
    As a result of the foregoing finding, Ms. Izurieta is debarred for 
a period of 30 years from importing articles of food or offering such 
articles for import into the United States, effective (see DATES). 
Under 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 Ms. Izurieta 
is a prohibited act.
    Any application by Ms. Izurieta for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2011-N-0589 and sent to the Division of Dockets Management (see 
ADDRESSES). All such submissions are to be filed in four copies. The 
public availability of information in these submissions is governed by 
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 4, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-542 Filed 1-12-12; 8:45 am]
BILLING CODE 4160-01-P