Fabrica Confecciones Soto, Inc. – FDA Warning Letter, Jul 24, 2015

The FDA inspected F?brica & Confecciones Soto, Inc.'s food manufacturing facility in Can?vanas, PR, from July 8-24, 2015, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Specifically, their "Tacos de Camarones" (Shrimp Tacos) product was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because it was prepared, packed, or held under insanitary conditions.

The primary violation cited was the firm's HACCP plan for "Tacos de Camarones," which includes shrimp and imitation crab meat, failed to list reasonably likely food safety hazards. These omitted hazards include undeclared allergens (shrimp, fish, crab, wheat, eggs, soy, and milk) and undeclared food and color additives (sulfiting agents and FD&C Yellow #5), violating 21 CFR 123.6(a) and (c)(1).

The firm's August 12, 2015, response to the FDA-483 was deemed inadequate, as it did not provide a complete revised HACCP plan and failed to identify the need for a critical control point at labeling review. The FDA requires a written response within fifteen working days, outlining specific