Port Bolivar Fisheries, Inc. 20-Dec-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

Dallas District

4040 North Central Expressway

Dallas, Texas 75204-3145

December 20, 2001

Ref: 2002 -DAL-WL-09

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Mr. Vinh Q. Tran

President

Port Bolivar Fisheries, Inc.

4154 Pine Crest Trail

Port Bolivar, Texas 77059

Dear Mr. Tran:

We inspected your seafood operation at 340 West French Town Rd., Port olivar, Texas, on December 11, 2001, and found that you have serious deviations from Title 21 of the Code of Federal Regulations (21 CFR) Part 123. These deviations cause your seafood products to be in violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find this Act and the Seafood HACCP regulations through links in FDA?s homepage at www.fda.gov.

Our inspection revealed your processing of seafood products deviates from the

regulations contained in 21 CFR Part 123 as follows:

You must have a written HACCP plan to control food safety hazards that are

identified as reasonably likely to occur, to comply with 21 CFR 123.6(b).

However, your firm does not have a HACCP plan for your gulf shrimp to

control the food safety hazard of sulfites.

You must adequately monitor sanitation conditions and maintain complete

sanitation control records that document monitoring and corrections, to

comply with 21 CFR 123.1 1(b) and (c). However, your firm did not have

sanitation monitoring records or procedures in all eight areas of sanitation.

Your firm did not have backflow prevention devices for each of the water

faucets inside the facility, shrimp totes containing processed gulf shrimp were

stored directly on the floor, the restroom did not have running hot water, toxic

compounds were not properly stored and live insects were noted inside the

production room during the inspection.

Please provide documentation that you have successfully completed seafood

HACCP training or provide other evidence that you are qualified through job

experience to develop and reassess your firm?s HACCP plan to comply with 21

CFR 123.8 (a) (3).

This letter is not intended to be an all-inclusive list of deficiencies at your facility.

At the conclusion of the inspection your firm was issued a Form FDA-483 which

is a list of the Investigators? observations of deviations noted during the

inspection. A copy of the FDA-483 is enclosed. It is your responsibility to ensure

adherence to each requirement of the Act and regulations.

You should know that this serious violation of the law may result in FDA taking

regulatory action without further notice to you. These actions include, but are not

limited to seizure, and/or obtaining a court injunction against further marketing of

your seafood products.

It is necessary for you to take action on this matter now. Please let this office

know in writing within fifteen (15) working days from the date you receive this

letter what steps you are taking to correct the problems. We also ask that you

explain how you plan to prevent these violations from happening again. If you

need more time, let us know why and when you expect to complete your

corrections. Your reply should be sent to Gwendolyn Sue Gilbreath, Compliance Officer, at the above address.

Sincerely,

Sylvia Y. Yates for

Michael A. Chappell

Dallas District Director