D’Andrea Foods Inc. – FDA Warning Letter, Feb 15, 2019

On February 11 and 15, 2019, the FDA inspected D’Andrea Foods Inc.'s seafood warehouse and distribution facility at 378 Pleasant Street, East Bridgewater, MA. The inspection revealed a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123).

The firm's refrigerated, ready-to-eat (rRTE) seafood salads and tuna salads are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) because they were prepared, packed, or held under insanitary conditions. Specifically, the firm lacks an adequate HACCP plan to control the food safety hazards of pathogenic bacteria growth and toxin formation in rRTE seafood salads, and pathogenic bacteria growth, toxin formation, and scombrotoxin (histamine) formation in rRTE tuna salads.

A response from the firm on March 5, 2019, to the Form FDA-483 was deemed inadequate as it did not provide information indicating a hazard analysis or an adequate HACCP plan had been implemented. The FDA expects the HACCP plan to list reasonably likely hazards, critical control points, critical limits, monitoring, verification procedures, and a recordkeeping system.

Failure to promptly correct these violations may result in further action