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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Lubar Seafood Corp. 19-Feb-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Food and Drug Administration

Florida District

555 Winderley Place

Suite 200

Maitland, Florida 32751

Telephone 407-475-4700

Fax: 407-475-4768

VIA HAND DELIVERY

Re: Customs Entry No. WKV-0035441-0

Product: Beltfish

Warning letter

FLA-02-24

Mauricio Rafael Barcia, President

Lubar Seafood Corp.

2665 S. Bayshore Drive

Suite 900

Miami. FL 33133

Dear Mr. Barcia:

The Food and Drug Administration (FDA) attempted to sample a shipment of Beltfish in

Accordance with our notice of sampling dated, January 9, 2002 under entry number WKV-0035441-0 and found that the entire shipment was not available for FDA examination. Title 21 Code of Federal Regulations Section 1.90 requires the importer to hold an entry intact pending receipt of a "May Proceed Notice" or "Release Notice" from FDA. We have requested the U.S. Customs Service (Customs) to order redelivery of the unavailable portion of the entry.

Failure to promptly correct this violation and prevent future violations may result in regulatory action without further notice such as seizure, injunction, or detention without physical examination of further shipments. It is your responsibility, as the importer, to ensure that imported products meet all the requirements of the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder.

We request a response in writing within fifteen (15) working days of receipt of this letter outlining the specific steps you have taken to prevent the recurrence of the violation. 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, 6601 NW 25th Street, P.O. Box 59-2256, Miami, Florida 33159-2256.

Sincerely,

Emma R. Singleton

Director, Florida District