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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Almacen De Dulce Corporation 15-Feb-02

DEPARTMENT of Health and Human Services

Food and Drug Administration

4040 N. Central Expressway

Suite 300

Dallas, Texas 7504

WARNING LETTER

Ref: 2002-SWID-WL-3

February 15, 2002

FEDERAL EXPRESS

Fernando Acosta, President

Almacen De Duke Corporation

909 South Greenwood Avenue

Montebello, CA 90640

Dear Mr. Acosta:

On January 16, 2002, we attempted to examine a shipment of "Patty? s Lollipops" offered

for import (imported) into the United States by your firm as invoiced and declared to

U.S. Customs Service on the same date under entry number EU6-0019205-5. Our

examination revealed the actual product to be "Dulmex Brand Hot Tamarind Lollipops."

Misrepresenting the product as Patty? s Lollipops at the time of entry appears to be an

attempt to circumvent our detention without physical examination for products

containing tamarind.

In addition, during the time period from 05/07/01 - 07/23/01 we have refused multiple

shipments of your products. We have contacted US Customs and it appears that none

of these entries have been redelivered for exportation and/or destruction under USCS

or FDA supervision as required by the redelivery demands issued to you by US

Customs. These entries and the dates redelivery was demanded by US Customs are

as follows: Entry Numbers 965-0073049-2, redelivery demanded 5/l 5/01; 965-0073256-

3, redelivery demanded 512101; 965-0073326-4, redelivery demanded 5/24/01; 965-

0073497-3, redelivery demanded 5124101; 965-0073784-4, redelivery demanded 6/7/01;

965-0074143-2, redelivery demanded 6/27/01; 965-0074309-9, redelivery demanded

g/20/01 ; 965-0074310-7, redelivery demanded 8/l/01 ; and 9650074486-5, redelivery

demanded g/20/01. It appears that these entries have been distributed into U.S.

commerce without FDA release. This is a violation of 21 USC 381(a) and 21 CFR

Section 1.90 that requires an importer to hold an imported article and not distribute it

pending receipt of the results of examination. In conjunction with this letter, we are

requesting that US Customs assess liquidated damages for failure to redeliver the

entries noted above.

We have also recommended that the U.S. Customs Service require that future

shipments of food imported by your fit-m be held in secured storage. Secured storage

will be under the supervision and direction of U.S. Customs, such as in a bonded

warehouse. You will be responsible for all costs incurred at secured storage.

Within 15 working days of receipt of this letter, notify this office in writing of the specific steps you have taken to prevent recurrence.

Your reply should be addressed to:

Vincent F. lacono, Compliance Officer

U.S.Food and Drug Administration

Otay Mesa Port of Entry

9777 Via De La Amistad #131

San Diego, CA 92154

Should you have any questions related to this letter, you may also contact Mr. lacono at

619-661-3273 ex 229.

Sincerely,

Robert J. Deininger

Southwest Import District

District Director