Seafood companies operating without an adequate Hazard Analysis and Critical Control Point (HACCP) plan often produce only a product or two.

That’s not the case at Capt’n Chucky’s Crab Cake Company, LLC, a seafood processing company in Newtown Square, PA.  It makes Smith Island Crab Cakes, Cold Formed Jumbo Crab Lump Crab Cakes (Premium Breaded Jumbo Lump Crab Cake), Cold Formed Jumbo Crab Cakes, Rock Hall Crab Cakes, Creamy Crab Cakes (Crab Critters Appetizers, Maryland Crab Soup, Imperial Breaded Jumbo Lump Crab Cake, Imperial Breaded Stuffed Shrimp, and Breaded Shrimp Cake.

And according to a July 21 warning letter from the U.S. Food and Drug Administration (FDA), all of these Capt’n Chucky’s products are “adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

FDA inspected Capt’n Chucky’s last Jan. 31 to Feb. 10, finding the following “significant violations:”

— No seafood HACCP plan for Imperial Crab Cake, Shrimp Cake and Stuffed Shrimp to control the food safety hazards of pathogen growth, toxin formation, undeclared sulfites and allergenic substances.

— No monitoring records for such actions as setting temperatures for “cooking soup.”

— Failure to monitor sanitation conditions and practices.  FDA inspectors observed employees with mustaches working with no hair restraints over their facial hair and making bare-skin contact with crabmeat.

— Failure to maintain sanitation control records for water safety, cleanliness of food contact surfaces, defense against cross contamination, maintenance of hand washing and toilet facilities, and protection of food, food packing material, and food contact surfaces from chemical, physical and biological contaminants.

— Not listing the risk of Staphylococcus aureus and toxin formation for the Smith Island Crab Cake Battered & Bread. Hazard analysis for each fish product must include food safety hazards that are reasonably likely to occur. 

The FDA said a HACCP plan must list monitoring procedures and their frequency for each critical control point. The HACCP plan must also list critical limits that must be met including “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.”

In the warning letter, FDA says some of the corrective actions included in the company’s HACCP plan “do not appear to prevent distribution of potentially unsafe products.”  

Capt’n Chucky’s is being urged to rewrite its seafood HACCP to include corrective actions that will “accomplish both correcting the cause of the deviations and preventing potentially adulterated products from entering commerce.”

FDA also said it found numerous label violations at the Pennsylvania seafood company.  Most involved the failure to list allergens and artificial flavors and colors, but some involved improperly listed weights, measures and sizes.

The Philadelphia district of FDA gave Capt’n Chucky’s 15 working days to notify the agency of the corrective actions taken to eliminate the violations outlined in the warning letter.

FDA’s Philadelphia district also issued a June 14 warning letter to Culinary Crossing Inc., a Harleysville, PA seafood processing facility that makes Seafood Soups.

Culinary Crossing’s seafood HACCP did not list a critical control point to control Clostridium botulinum growth and toxin formation, according to FDA. 

“Clostridium botulinum growth and toxin formation is a reasonably likely hazard for your products because they are packaged in oxygen impermeable packaging materials,” the warning letter says.  “Moreover, your plan lists the hazard of “toxin production” and references a storage temperature of 38¬∞F, which is the recommended temperature for storing refrigerated products packed in oxygen impermeable materials when there are no secondary barriers to Clostridium botulinum toxin formation.”

FDA also gave the seafood soup maker 15 working days to respond to the agency’s concerns.