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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Patriot Foods, LLC 03-Jun-02

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


VIA FEDERAL EXPRESS

Food and Drug Administration
555 Winderley Pl., Ste. 200
Maitland, FL 32751

Ref Customs Entry No. WKV-0036537-4
Product: Frozen Lobster Tails (23,320 lbs.)

WARNING LETTER
FLA-02-46
June 3, 2002

Cauley Dennis, President
Patriot Foods, L.L.C.
800 Brickell Avenue
Suite 201
Miami, Florida 33131

Dear Mr. Dennis:

The Food and Drug Administration (FDA), on February 12, 2002, attempted to examine a shipment of frozen lobster tails in accordance with our Notice of FDA Action, dated February 12, 2002. The shipment was offered for entry into the United States by your firm on February 12, 2002, under the above referenced entry number. Although FDA requested documents for this entry on February 13, 2002, 50 cases of the adulterated product were shipped on March 8, 2002, into interstate commerce.

FDA collected physical samples of the lobster tails that revealed the presence of Salmonella. A Notice of FDA Action (refusal) was issued on April 3, 2002.

On April 18, 2002, U. S. Customs Service (Customs) notified FDA that 10 cases ([redacted] lbs.) of frozen lobster tails were not redelivered into Customs? custody pursuant to the Notice of FDA Action (refusal) dated April 3, 2002. The consignee, Penguin Frozen Foods, Inc., confirmed by letter dated April 19, 2002, that 10 cases of the original shipment could not be recovered and redelivered to Customs custody. In addition, FDA examination of the remaining portion of the lobster tails in this entry on April 23, 2002, revealed that 10 master cartons and 1 partial case (a total of [redacted] lbs.) were unavailable.

This is in violation of Title 21, Code of Federal Regulations, Section 1.90, which requires the importer to hold an entry intact pending receipt of a "May Proceed Notice" or "Notice of Release" from FDA.

Failure to promptly correct this situation and prevent future premature distribution of imported products may result in requiring that future shipments be held in secured storage. Secured storage will be under the supervision and direction of U.S. Customs Service, such as in a bonded warehouse. You will be responsible for all costs incurred in secured storage.

We request a response in writing within fifteen (15) working days of receipt of this letter outlining the specific steps you have taken to correct the violation, including an explanation of each step being taken to prevent recurrence. In the event that the product is still available for examination, you should inform Customs and FDA if and when redelivery is accomplished.

Your written reply should be addressed to the Food and Drug Administration, Attention: Christine M. Humphrey, Compliance Officer, P.O. Box 59-2256, Miami, Florida 33 159-2256.

Sincerely,

/s/

Emma R. Singleton

Director, Florida District