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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Chicken of the Sea International 28-Jan-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Southwest Import District

4040 N. Central Expressway, Suite 300

Dallas, Texas, 75204

Telephone: 214-253-5330

FAX: 214-253-5316

January 28, 2002

Ref: 2002-SWID-WL-02

Entry # F62-1001874-4

WARNING LETTER

VIA Federal Express

Mr. Dennis Mussell, President

Chicken of the Sea International

4510 Executive Drive, Suite 300

San Diego, CA 92121-3029

Dear Mr. Mussell:

On January 25, 2001, the Food and Drug Administration (FDA) attempted to examine a

shipment of -cartons of Premium Light Tuna in Pouches consigned to your firm

from Thai Union Frozen Products Public Co. Ltd., Bangkok, Thailand. FDA confirmed

that this lot of tuna has been completely distributed into U.S. commerce without a

proper FDA release.

This shipment of tuna was sampled on May 30, 200l and examined by FDA for

decomposition. The lot was found to be violative for decomposition and was detained on

June 14, 2001. Following receipt of the notice of detention, Chicken of the Sea

requested and received an extension of time to prepare a reconditioning request for the

entry. The request was initially denied. The latest revision received from Chicken of the

Sea was approved on December 3, 200l. On December 11, 2001, FDA received a fax

of a letter from Chicken of the Sea providing information that the entire shipment may

no longer be available for sampling and examination.

On January 25, 2002, FDA attempted to examine this entry of tuna. This shipment was

not available for FDA to examine and was distributed out of Shippers Warehouse,

Dallas, Texas with shipments made between June 5, 200l and November 27, 200l.

Distribution from this shipment of tuna began 5 days following the FDA sample

collection on May 30, 2001. It is a violation of 21 USC 381 (a) and Title 21 of the Code

of Federal Regulations Section 1.90 that requires the importer to hold an imported

article and not distribute it pending receipt of the results of FDA examination of the

sample. Shipments of this lot were distributed even after the FDA issued a notice of

detention indicating adulteration of this tuna due to the presence of decomposition. It is

a prohibited act (21 USC 331(a)) to introduce into interstate commerce a food that is

adulterated according to 21 USC 342(a)(3) "if it consists in whole or in part of any filthy, putrid, or decomposed substance". Failure to promptly correct this situation may result in requiring that future shipments be held in secured storage. Secured storage will be under the supervision and direction of Customs, such as in a bonded warehouse.

You will be responsible for all costs incurred in secured storage.

In addition, we have requested that Customs demand redelivery of this shipment.

Failure to redeliver the missing product to Customs? custody may result in an

assessment of liquidated damages at a later date.

Within 15 working days of receipt of this letter notify this office in writing of the specific

steps you have taken to correct this violative situation, including an explanation of each

step being taken to prevent recurrence and any attempts to retrieve any of this violative

product in U.S. commerce. In the event that the product is still available for examination,

you should inform Customs and FDA if and when redelivery is accomplished.

Your response should be addressed to Deborah M. Floyd, Compliance Officer, at the

address noted in the letterhead.

Sincerely,

Robert J. Deininger

District Director