FDA WARNING_LETTER - Bestway Sandwiches, Inc. dba Bestway Foods - March 04, 2015

On June 18, 2015, the FDA issued a Warning Letter to Bestway Sandwiches, Inc. following an inspection of their seafood processing facility in San Fernando, California, on February 24, 27, and March 4, 2015. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their tuna salad and crab pasta products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The firm did not respond to the FDA483 issued on March 4, 2015.

Key violations included: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for "Fully Cooked, Not Shelf Stable Seafood Products (Tuna Salads/Crab Pasta)" failed to list reasonably likely food safety hazards such as undeclared allergens, scombrotoxin (histamine) formation in tuna products, and pathogen growth and toxin formation. 2. **Missing Critical Control Points (21 CFR 123.6(a) and (c)(2)):** The HACCP plan did not identify critical control points for: * Storage of in-process and finished tuna salad and crab pasta products in the