FDA WARNING_LETTER - Imperial Valley Foods Inc. - August 14, 2014

On July 29 - August 14, 2014, the FDA inspected a food manufacturing firm at 335 E. Boardman St., Youngstown, OH, and found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. The firm's tuna salad was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because it was prepared, packed, or held under insanitary conditions.

The primary violation was the firm's failure to have and implement a written HACCP plan for tuna salad to control the food safety hazards of scombrotoxin (histamine) formation and allergens, as required by 21 CFR 123.6(a) and (b). The firm's August 25, 2014, response was inadequate, as it incorrectly argued that pre-retorting tuna salad processing was not a hazard because it did not exceed critical limit time/temperature parameters from the Fish & Fisheries Products Hazards & Controls Guidance. The FDA clarified that critical control points exist wherever control can prevent, eliminate, or reduce a food safety hazard, regardless of whether specific critical limits are exceeded.

The firm is responsible for complying with the Act, seafood HACCP regulations (21 CFR Part 123), Current Good Manufacturing Practice regulations (21 CFR