Woolery Enterprises, Inc. dba Will's Fresh Foods – FDA Warning Letter, May 8, 2012

On April 25, 26, 27, and May 8, 2012, the FDA inspected Woolery Enterprises, Inc. dba Will's Fresh Foods in San Leandro, California, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's refrigerated, ready-to-eat tuna salad and seafood salad were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) due to insanitary conditions.

Key violations include: 1. Failure to conduct a proper hazard analysis for histamine formation in refrigerated, ready-to-eat tuna salad during cooler storage, as required by 21 CFR 123.6(a) and (c)(1). The firm's "Temperature abuse of Seafood Salad" HACCP plan was used for all seafood but did not list this specific hazard. 2. Failure to list critical control points (CCPs) in the HACCP plan for "Temperature abuse of Seafood Salad," including Seafood Cooler Storage (thawing) for pathogen/toxin control, Metal Detector for metal inclusion, Finished Product Labeling for allergens, and Refrigerated Storage for histamine/pathogen/toxin control, violating 21 CFR 1