FDA WARNING_LETTER - Frank L Harter & Sons Inc - July 07, 2011

The FDA inspected Frank L Harter & Sons Inc. from June 27 to July 7, 2011, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and labeling regulations (21 CFR 101).

Key violations include: - **Seafood HACCP:** The firm lacks HACCP plans for Albacore Tuna Salad and Chunky Tuna Salad to control scombrotoxin formation and pathogen growth, violating 21 CFR 123.6(a) and (b). Additionally, sanitation monitoring records for pest exclusion were not maintained, violating 21 CFR 123.11(c). These failures render the seafood products adulterated under 21 U.S.C. § 342(a)(4). - **Labeling:** Red Skin Potato, Hawaiian Delight, Three Bean, and Pasta Salads, and French Onion Dip are misbranded under 21 U.S.C. § 343(i)(2) because all ingredients, especially sub-ingredients of multi-component ingredients (e.g., salad dressing, sweet pickle relish, sour dressing, marshmallows, beans), are not declared as required by 21 CFR 101.4. Ingredients were also not declared by their common or usual names (e.g., "cornsweetener" instead of