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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sam Rust Seafood Inc. Response Letter

Sam Rust Seafood Inc.

September 25, 2006


Food and Drug Administration
Jose R. Hernandez, Compliance Officer
2810 North Parham Road, Suite 160
Richmond, VA. 23294

Dear Mr. Hernandez,

Sam Rust Seafood Inc
P O. Box 9760
Hampton, VA. 23670

This letter is in response to warning letter 06-BLT-1 dated April 5, 2006 to Sam Rust Seafood Inc. concerning an inspection conducted March 2-3 and March 6-7 2006 by Investigator Hudson at our facility.

Let me preface this letter by stating that Sam Rust Seafood Inc. is committed to fully complying and participating with all HACCP regulations and Good Manufacturing practices. Since HACCP's inception in December 1997, we have strived to maintain an updated and effective plan that would further assure a fresh and safe product for our customers. I want to thank the FDA for the thoroughness of your inspections and welcome all input from you as we work together to make us a better company.

My concern for the letter posted on the web is that current or potential new customers may read it and misinterpret the content as to the scope of products that are in question and also the nature of the violations and what they actually mean. I will address each point below.

Point #1
The language used " (e.g., renders the fish or fishery products adulterated within the meaning of section 402(a) (4), of the Federal Drug and Cosmetic Act (the Act), 21 (U.S.C.) United States Code 342(a) (4). Accordingly, your seafood products, including herring, vacuum packaged salt cured herring, and herring roe; seafood products packed in hermetically sealed containers (e.g., glass jars with metal lids) such as: pickled herring, herring in wine, herring in cream, and caviar; and ready to eat seafood products, such as Cajun krab dip, Cajun smoked salmon flavored spread, and marinated mussel salad are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health . You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov. "

The previous paragraph states, "accordingly your seafood products" which to me sounds like al! of our seafood products, including those listed are adulterated and have been held under insanitary conditions and may be injurious to health. I feel the choice of language could be misleading and to your average person who reads this, could lead them to some incorrect conclusions about Sam Rust Seafood Inc. The fact is that these products listed represent less than 1% of our total sales per year. Not dismissing the importance that any and all product we sell, no matter how much, should be documented and handled properly. We did not know that it was necessary to include these products in our HACCP plan. We were under the impression that if a fresh products disposition had been significantly changed (e.g. cooked, salted, marinated, pickled, etc.) it did not fall under HACCP guidelines. That is why they were not included in our plan. Investigator Hudson informed us that we were out of compliance and we adjusted our HACCP plan accordingly. With our normal previous methods of receiving I am absolutely sure .the products in question would not have posed a danger to anyone's health. After offering these products for more than 15 years, I am not aware of any incidents regarding any of these products. The only difference is we were not documenting the information at receiving as we now know we should. We have always worked closely with State and Federal inspectors in the past, but have no record or remembrance of "vacuum packaged herring" or "hermetically sealed containers" being addressed from anyone of them until now.

Point #2
Also, you noted we did not record monitoring observations (internal temperatures) at the receiving critical control point for fresh herring and herring roe that we received. This is a seasonal fish and it did indeed get received without internal temperature documentation, but it was received surrounded by ice as documented on our receiving log. That in it self would qualify the fish as being received properly, except for the fact that our NACCP plan includes documenting internal temperatures of histamine producing fish.

Point #3
We did not take appropriate corrective action when receiving pasteurized crabmeat on 8/18/04 when we received it at 42 degrees F, and on 12/15/05 when we received cooked crab claws at 42.8 degrees F. Our critical limit for receiving crabmeat is 40 degrees F. Our employee should have immediately surrounded the product with ice and put it under refrigeration, then rechecked the disposition of the product and the temperature again within an hour. Then this process should have been documented on an "Unusual Occurrence Form" to note the corrective action taken. In reality, the 2 to 3 degrees above this critical limit would not have compromised the product in question, nor rendered it injurious to health, but we will strive to maintain 100°lo compliance at all times. The same employee of ours received both deliveries and has been educated on the proper procedure in situations such as these. To put this occurrence in the proper perspective, I would like to note that we literally receive hundreds of shipments of crabmeat per year and that this breach was an exception rather than the rule for Sam Rust Seafood.

Again, I would like to stress the commitment that Sam Rust Seafood Inc. has to fully complying with all State and Federal Regulators and the commitment we have to delivering the freshest and safest seafood available. I hope that my explanation addressing the concerns of this warning letter will add more clarity to its readers about the nature of these violations.

Sincerely,

/s/
Glen Keener
Operations Manager
Sam Rust Seafood Inc.