IL Pastaio, Inc. – FDA Warning Letter, Aug 26, 2014

On October 10, 2014, the FDA issued a Warning Letter to Il Pastaio, Inc. following an inspection from August 25-26, 2014, at their San Jose, CA facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123.

The primary violation cited was the firm's failure to conduct a hazard analysis and implement a written HACCP plan for their frozen seafood ravioli products, including those containing lobster, shrimp, and smoked salmon. This omission means the firm is not controlling food safety hazards such as pathogens, potential toxin formation, and undeclared allergens, as required by 21 CFR 123.6(a) and (b). Consequently, their seafood products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), as they were prepared, packed, or held under insanitary conditions that may render them injurious to health.

The FDA requires Il Pastaio, Inc. to develop a HACCP plan that lists reasonably likely hazards and includes critical control points, critical limits, monitoring procedures, and recordkeeping activities, as per 21 CFR 123.6(c). The letter references the "Fish and Fishery Products Hazards and Controls Guidance" for assistance.

Failure to promptly correct