The Box Lunch Company, Inc. – FDA Warning Letter, Nov 9, 2012

The FDA inspected The Box Lunch Company, Inc.'s seafood processing facility from October 30 to November 9, 2012, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The company's refrigerated ready-to-eat tuna salad products, including Tuna Salad Sandwiches and Tuna Salad, are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

Key violations include: 1. Failure to conduct a proper hazard analysis for tuna salad products, specifically omitting scombrotoxin (histamine) formation due to time/temperature abuse and undeclared allergens, as required by 21 CFR 123.6(a) and (c)(1). 2. Failure to list critical control points in the HACCP plan for tuna salad products, specifically lacking control points for "In-Process Product Storage" to manage pathogen growth and toxin formation during tuna holding, and "Finished Product Storage" for controlling pathogen growth and toxin formation during finished product storage, as required by 21 CFR 123.6(a) and (c)(2).

The FDA warns of potential further actions, including product seizure, injunctions, and assessment of re-inspection fees. The company must respond in writing within fifteen working days