[Federal Register Volume 75, Number 165 (Thursday, August 26, 2010)]
[Notices]
[Pages 52534-52535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21258]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0213]
Su Van Ho: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 52535]]
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the act) debarring Su
Van Ho for a period of 15 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. Ho was convicted of three
felonies under Federal law for conduct relating to the importation into
the United States of an article of food. Mr. Ho was given notice of the
proposed debarment and an opportunity to request a hearing within the
timeframe prescribed by regulation. As of July 15, 2010, Mr. Ho failed
to respond. Mr. Ho's failure to respond constitutes a waiver of his
right to a hearing concerning this action.
DATES: This order is effective August 26, 2010.
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), Office of Enforcement, Office of Regulatory Affairs,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
240-632-6844.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the 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 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 August 4, 2009, the United States District Court for the Central
District of California accepted Mr. Ho's guilty plea and entered
judgment against him for the offenses of: Smuggling, Causing an Act to
be Done in violation of 18 U.S.C. 545, Concealing a Material Fact by
Trick or Device in violation of 18 U.S.C. 1001(a)(1) and Receipt of an
Adulterated Food and Delivery Thereof for Pay in violation of 21 U.S.C.
331(c), 333(a)(1), and 342(a)(3).
FDA's finding that debarment is appropriate is based on the three
felony convictions referenced herein for conduct relating to the
importation into the United States of any food. The factual basis for
those convictions is as follows: Between at least January 1, 2003,
through September 16, 2004, Mr. Ho owned and operated VincentSeafood
and Trading, a frozen seafood import and distribution business. On or
about August 20, 2004, in violation of 18 U.S.C. 545 and 2(b), Mr. Ho
knowingly and willfully, with the intent to defraud the United States,
did pass and cause to be passed through the customshouse a fraudulent
commercial invoice that falsely described 610 cartons of Frozen Silk
Worm as ``Frozen Dade'' fish and 461 cartons of Pineapple Brand Betel
Nut as ``Frozen Palmnut.''
On or about September 16, 2004, in violation of 18 U.S.C.
1001(a)(1), Mr. Ho knowingly and willfully concealed and covered up by
trick, scheme, or device a material fact. Specifically, he was ordered
by FDA to export or destroy 118 cartons of frozen Featherback fish from
import shipment N08-0026008-0 that contained Salmonella bacteria, with
verification of such exportation or destruction by FDA. Mr. Ho
concealed and covered up the material fact that he had improperly sold
103 cartons of the contaminated Featherback fish from import shipment
N08-0026008-0 by a trick, scheme, or device in which he substituted 103
cartons of Featherback fish from other, unrelated import shipments and
presented the substitute cartons of fish to FDA for verified
exportation or destruction as the contaminated fish from import
shipment N08-0026008-0.
Between on or about January 17, 2004, and September 16, 2004, in
violation of 21 U.S.C. 331(c), 333(a)(1), and 342(a)(3), Mr. Ho
received in interstate commerce and delivered in exchange for payment
an adulterated food, namely, frozen Featherback fish from import
shipment N08-0026008-0 that was contaminated with Salmonella bacteria.
As a result of his conviction, on June 10, 2010, FDA sent Mr. Ho a
notice by certified mail proposing to debar him for a period of 15
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 act that Mr. Ho was convicted of
three felonies under Federal law for conduct relating to the
importation into the United States of an article of food, and a
determination, after consideration of the factors set forth in section
306(c)(3) of the act (21 U.S.C. 335a(c)(3)), that the full periods of
debarment shall run consecutively as provided by section
306(c)(2)(A)(iii) of the act (21 U.S.C. 335a(c)(2)(A)(iii)). The
proposal also offered Mr. Ho 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. Ho 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 act, and under
authority delegated to the Director (Staff Manual Guide 1410.35), finds
that Mr. Su Van Ho has been convicted of three felonies under Federal
law for conduct relating to the importation of an article of food into
the United States and that the full periods of debarment shall run
consecutively under section 306(c)(2) of the act (21 U.S.C.
335a(c)(2)).
As a result of the foregoing finding, Mr. Ho is debarred for a
period of 15 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 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. Ho is a
prohibited act.
Any application by Mr. Ho for termination of debarment under
section 306(d)(1) of the act should be identified with Docket No. FDA-
2010-N-0213 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: August 12, 2010.
Howard R. Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2010-21258 Filed 8-25-10; 8:45 am]
BILLING CODE 4160-01-S