FDA WARNING_LETTER - Dolce, L.L.C. - February 11, 2010

The FDA inspected a seafood processing facility at 221 S. Hancock St., Unit 2, Louisville, KY, on December 17-18, 2009, and again on January 27 and February 11, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering products like tuna salad, tuna salad sandwiches, and salmon cakes adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Lack of HACCP Plans:** The firm failed to conduct a hazard analysis and implement written HACCP plans for tuna salad and tuna salad sandwiches to control histamine formation, pathogen growth, and allergens. Similarly, no HACCP plan existed for salmon cakes to control allergens, pathogen survival, and pathogen growth/toxin formation, violating 21 CFR 123.6(a) and (b). 2. **Misbranding - Undeclared Allergens:** "Salmon Cakes" and "Ooohmami Vegan Burger" were misbranded under Section 403(w) of the Act because labels failed to declare all major food allergens. Specifically, "Salmon Cakes" contained undeclared milk (from sour cream) and wheat (from panko), and "Ooohmami Vegan