2012-1489. Yuri Izurieta: Debarment Order

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Yuri Izurieta for a period of 20 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. 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. Mr. Izurieta was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of November 10, 2011 (30 days after receipt of the notice), Mr. Izurieta had not responded. Mr. Izurieta's failure to respond constitutes a waiver of his right to a hearing concerning this action.

DATES:

This order is effective January 25, 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, Division of Compliance Policy (HFC-230), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, [phone].

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 (21 U.S.C. 335a(b)(3)(A)), 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 United States District Court for the Southern District of Florida, Mr. Izureita 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 United States District Court for the Southern District of Florida entered judgment against Mr. Izurieta on July 29, 2011.

FDA's finding that debarment is appropriate is based on the felony conviction's referenced herein for conduct relating to the importation into the United States of any food. The factual basis for these convictions is as follows: As alleged in the indictment that was filed against Mr. Izurieta, beginning on or about April 18, 2007, and continuing through about December 23, 2010, in violation of 18 U.S.C. 371, Mr. 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, Mr. 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.

Mr. Izurieta worked at Naver Trading Corp., a registered Florida corporation engaged in the business of importing and distributing food, including dairy products, in local and interstate commerce. While working there, Mr. Izurieta caused dairy products and other food to be imported from Honduras and Nicaragua. Despite requests from FDA, Mr. Izurieta failed 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, Staphylococcus aureus, and Salmonella. Mr. 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. Mr. 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. Mr. Izurieta then imported and 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, Mr. Izurieta fraudulently and knowingly imported and brought into the United States merchandise contrary to law. Further, Mr. 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 his conviction, on September 28, 2011, FDA sent Mr. Izurieta a notice by certified mail proposing to debar him for a period of 20 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 Mr. 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 he conspired to commit offenses related to the importation of dairy products into the United States and imported and brought into the United States merchandise contrary to law. It was also based on a determination, after consideration of the factors set forth in section 306(c)(3) of the FD&C Act (21 U.S.C. 335a(c)(3)) that Mr. Izurieta should be subject to a 20-year period of debarment. The proposal also offered Mr. Izurieta an opportunity to request a hearing, providing him 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. Izurieta failed to respond 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 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 Mr. Yuri 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 he is subject to 20 years of debarment.

As a result of the foregoing finding, Mr. Izurieta is debarred for a period of 20 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 Mr. Izurieta is a prohibited act.

Any application by Mr. Izurieta for termination of debarment under section 306(d)(1) (21 U.S.C. 335a(d)(1)) of the FD&C Act should be identified with Docket No. FDA-2011-N-0592 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 11, 2012.

Armando Zamora,

Acting Director, Office of Enforcement, Office of Regulatory Affairs.