FDA WARNING_LETTER - Bruno's of Duluth, Inc. - February 29, 2008

The FDA inspected Bruno's of Duluth, Inc.'s seafood processing facility from February 27-29, 2008, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice regulation for Foods (21 CFR 110).

The firm's New England Clam Chowder is adulterated because it lacks a HACCP plan to control pathogen growth, toxin formation, and pathogen survival through cooking, as required by 21 CFR 123.6(a) and (b). The submitted "HACCP Plan" was merely a recipe. Additionally, the firm failed to maintain sanitation control records for various critical areas, including water safety, food contact surface cleanliness, cross-contamination prevention, handwashing facilities, food protection, toxic chemical control, employee health, and pest exclusion, violating 21 CFR 123.11(c).

Several products, including Bruno's brand soups (Minnesota Wild Rice, Old Fashion Dumpling, Noodle, Split Pea, Bean), Old World Recipe brand flavor bases (Chicken, Ham), and private-label soups ([redacted] Old Fashion Dumpling, [redacted] Cream of Wild Rice, [redacted] Cream of Rice), are misbranded under 21 U.S.C. § 343(w) for failing to declare major