FDA WARNING_LETTER - Smith Family Frosted Foods LLC - February 01, 2012

The FDA inspected Smith Family Frosted Foods, LLC, from January 24 to February 1, 2012, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123), rendering their fish and fishery products adulterated. Additionally, labeling violations were identified under 21 CFR Parts 74 and 101, causing products to be adulterated and misbranded.

Key HACCP violations included the absence of HACCP plans for frozen breaded raw yellow lake perch fillets (to control *Staphylococcus aureus* toxin, allergens, metal inclusion) and refrigerated ready-to-eat seafood salads (to control *Clostridium botulinum* toxin). The firm also failed to adequately monitor sanitation conditions and practices, evidenced by improper employee hygiene, unsanitized equipment, and lack of monitoring for employee health, toilet facilities, and pest exclusion.

Labeling violations included failure to declare certified color additives (FD&C Yellow No. 5, No. 6, Red No. 40) by their proper names in ingredient statements for "House of Meats brand Shell Macaroni Salad." This product was also adulterated for containing an unsafe color additive. "Breaded Yellow Lake Perch" failed to list perch as an ingredient. "Granny Smiths Kitchen Seafood Pasta Salad" incorrectly declared imitation crabmeat components and failed to declare major food allergens (Pollock, cod, wh