An FDA inspection found that frozen entrees containing shrimp could be adulterated under the relevant legislation, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
After the inspection in November at the Jackson, Ohio facility, the FDA said it found serious violations of the seafood HACCP regulation due to a failure to comply with the section or operate in accordance with the necessary requirements.
The agency noted a response dated 17 December from the firm but added that it was “not adequate” because the deviations observed during the inspection were not corrected.
Violations detailed
The FDA listed significant violations in a warning letter sent at the end of last month to Joel Conner, chairman and chief executive officer of Bellisio Foods.
“You must conduct a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur...”
The agency said the firm’s response indicated that prerequisite programs are in place to cover allergens other than shellfish, such as wheat and milk but said a prerequisite program cannot be used in lieu of a critical control point to reduce or eliminate a hazard that is reasonably likely to occur.
“You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points…,” said the letter.
“However, your firm’s HACCP plan for frozen entrees containing shrimp does not list the sauce holding tank, the rework/carryover sauce, the pasta blanching, or the pasta filling processing steps as critical controls points to control the food safety hazard of pathogen growth and toxin formation.”
Cooking and cooling points
The FDA said the HACCP plan for frozen entrees containing shrimp lists a critical limit at the cooking and cooling critical control point that is not adequate to control the food safety hazard of pathogen growth and toxin formation.
“Specifically, the critical limit for cooking and cooling should include both time and temperature parameters. Your critical limit at the cooking and cooling critical control point only lists a minimum temperature.
“Additionally, your HACCP plan for frozen entrees containing shrimp lists a critical limit at the metal detection critical control point that is not adequate to control the food safety hazard of metals. Your critical limit does not ensure that all product goes through the metal detector and that there is no metal in the product.”