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Seafood Processors Get Warning Letters

A half dozen seafood processors spent much of May and June trying to get back into compliance with federal regulations.

It might be too much to say that the U.S. Food and Drug Administration is cracking down on the industry, but recently the agency has made public more warning letters sent to seafood processors than to any other food plants.

The letters went out between Jan. 13 and May 19, 2011.  FDA inspects seafood processors, issues them a copy of a Form 483 inspection report and follows up with a so-called warning letter. Most companies are given 15 working days to bring their operation into compliance with federal regulations, and to formally notify FDA about their actions.

It’s risky to ignore a warning letter because FDA’s next options include going to going to federal court to shut the company down and/or seizing the products to prevent food considered to be adulterated from entering interstate.

Here’s the rundown on which seafood processors have run afoul of FDA:

Seafood Processor: Franklin Foods Inc.

Location: Delray Beach, FL

Products: Smoked salmon cream cheese

FDA District:  New England

Warning Letter Date: Jan. 13, 2011

Issues:  Seafood Hazard Analysis and Critical Control Point (HACCP) violations, including failure to list the food safety hazard of Clostridium botulinum and allergens; and not listing monitoring frequency at the “storage” critical control point to control pathogens.

FDA said Franklin Foods also does not indicate how temperature will be monitored during refrigerated storage. FDA wants continuous monitoring with daily temperature and equipment checks.

Further FDA environmental sampling inside the seafood facility during a Sept. 16 through Oct. 26, 2010 inspection found the presence of Listeria, a pathogen that can cause life-threatening illnesses.

Seafood Processor: Dawn’s Foods Inc.

Location: Portage, WS

Products: Alaskan Krab, Deluxe Seafood, Tuna Macaroni, and Tuna salads and Cajun Krab and Smoked Salmon dips.

FDA District:  Minneapolis

Warning Letter Date: May 12, 2011

Issues: Seafood HACCP and other regulatory violations.  Because seafood salads are packaged in large (5 lb.) deep containers, there is a risk of Clostridium botulinum growth and toxic formation.  FDA recommends Dawn’s “adopt a secondary control strategy to prevent toxin formation.”

The Wisconsin seafood processor must set critical control points that will control pathogen growth, and some that were set were found to be inadequate.  FDA also had problems with the company’s record keeping and its corrective action plan.

Seafood Processor: Import Food Wholesale

Location: St. Paul, MN

Products: Smoked uneviscerated fish

FDA District:  Minneapolis

Warning Letter Date: May 13, 2011

Issues:  Violations of Seafood HACCP and Current Good Manufacturing Practice (CGMP) regulations.

Specifically, FDA said the seafood processor has not performed a hazard analysis for smoked uneviscerated fish to control the food safety hazard of Clostridium botulinum.

FDA said it considers uneviscerated fish over 5 inches that have been salt-cured, dried, or smoked, as well as products made from them, to be adulterated.

In addition, Import Food Wholesale was not registered with FDA as required by federal law.

Seafood Processor: Contes Pasta Company Inc.

Location: Vineland, NJ

Products: Frozen lobster

FDA District:  New Jersey

Warning Letter Date: May 16, 2011

Issues:  FDA said the seafood processor failed to take corrective action when a deviation from a critical limit occurs.  The warning letter said Contes Pasta failed to control temperatures while thawing frozen lobster and instead of immediately refrigerating the product, it was used to manufacture lobster ravioli.

FDA also charged that that Heart Shaped Lobster Ravioli was mislabeled because it did not list a a coloring additive.

Seafood Processor: Manolo and Son, LLC

Location: Alexandria, VA

Products: Canned pasteurized crabmeat

FDA District:  Baltimore

Warning Letter Date: May 16, 2011

Issues:  Serious violations of seafood HACCP regulations, including the fact that its HACCP plan is not adequate to control pathogen growth and toxin formation.

FDA recommends the company continuously monitor and record temperatures and have adequate ice on hand.

Seafood Processor: Natural Choice Distribution Company

Location: Oakland, CA

Products: Albacore tuna with ginger wasabi sandwich

FDA District:  San Francisco

Warning Letter Date: May 18, 2011

Issues:  Failure to have a HACCP plan for albacore tuna with ginger wasabi sandwich to control the food safety hazards of pathogens and Histamine toxin.

During an inspection last Feb. 8-22, FDA found Natural Choice was not monitoring for the prevention of cross contamination.  It said it found mold-like material on walls, employees packing potato salad into dirty plastic bins, and touching the inside surfaces for garbage cans and then continuing to assemble sandwiches.

The assembly and packing room lacked hand sanitizer and employees failed to sanitize food contact equipment. There were flies in the assembly room, FDA said.

Products were also found to be misbranded for not listing allergens and other ingredients.

Seafood Processor: Family Fresh Pack, LLC

Location: Belleville, WS

Products: Lobster Bisque, Shrimp Scampi, and Crab Creole

FDA District:  Minneapolis

Warning Letter Date: May 19, 2011

Issues:  “Serious violations” of seafood HACCP regulations, including failure to include controls for allergens, Clostridium botulinum, and food intolerance substances.   “Additionally, your firm is packaging the products in containers that are oxygen impermeable and thus create conditions conductive to Clostridium botulinum growth and toxin formation,” FDA said.

Also the critical limits for the seafood products involved were not adequate to control pathogen growth.  “The temperature ranges you have listed as critical limits for storage may result in  your product being held at temperatures that support pathogen growth for extended periods of time,” the warning letter says.  “We recommend continuously maintaining storage temperatures at or below 38 F.”

FDA also questioned the seafood processor’s record-keeping and sanitation practices, noting that employees were observed placing their fingers inside filled cheese cups while moving them to the scale without first washing and sanitizing their hands.

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