2010-21258. Su Van Ho: Debarment Order

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.