FDA WARNING_LETTER - Stewart's Processing Corp. - January 04, 2008

On January 3-4, 2008, the FDA inspected Stewart's Processing Corp.'s seafood processing facility in Saratoga Springs, New York, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The primary violation was the firm's failure to have and implement a written HACCP plan for refrigerated ready-to-eat seafood salad and refrigerated ready-to-eat tuna salad. This omission means the firm did not control the food safety hazards of pathogen growth and toxin formation in both products, and additionally, histamine formation in the tuna salad, as required by 21 CFR 123.6(a) and (b). Consequently, these products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

The FDA recommended including controls in the HACCP plan for receipt and storage to ensure products are maintained at or below 40°F, suggesting transportation records for products in transit over four hours and continuous cooler temperature monitoring with daily visual checks.

The firm must respond in writing within fifteen working days, detailing corrective actions, including their written HAC