FDA WARNING_LETTER - Boyko Foods, LLC - December 10, 2013

On December 10, 2013, the FDA inspected Boyko Foods, LLC, a seafood processing and sauce manufacturing facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The Golden Breaded Shrimp Patties were deemed adulterated because the firm lacked a HACCP plan to control hazards like pathogen growth, toxin formation, allergens, food additives, and metal detection. Although time/temperature records for batter existed, they were not consistently reviewed within seven days, and critical limit changes were not properly signed and dated.

Additionally, both Don Diego brand South American Sauce and Golden Breaded Shrimp Patties were misbranded. Key misbranding issues included: * Failure to declare the major food allergen "soybean" on labels. * Don Diego brand South American Sauce in bulk containers lacked any ingredient declaration. * Don Diego brand South American Sauce (retail) and Golden Breaded Shrimp Patties had incomplete ingredient lists, failing to declare sub-ingredients (e.g., for "Soy Sauce") and using inappropriate collective terms like "Seasonings." Specific ingredient declaration errors were noted for Shrimp Patties regarding "onion powder," "beef fibrin," and "fish extract." * Don Diego brand South American Sauce (retail) lacked a nutrition label, despite nutrition information being