FDA WARNING_LETTER - CFS Operating Limited - July 10, 2009

On June 29-July 10, 2009, the FDA inspected CFS Operating Limited d.b.a. Cloud's Food Service and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (cGMP) regulation (21 CFR Part 110). These violations render their tuna salad sandwiches and other ready-to-eat sandwiches adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR §123.6(a) and (c)(1)):** The HACCP plan for tuna salad sandwiches failed to list undeclared allergens (sulfites, fish, wheat, peanuts, soy, eggs, milk, tree nuts) and *Clostridium botulinum* growth and toxin formation as reasonably likely food safety hazards. The tuna salad contains tuna, sodium bisulfite, eggs, and soy flour, while the bread contains wheat flour, soy lecithin, and milk. The use of oxygen-restrictive film on tuna salad sandwiches necessitates a barrier to *C. botulinum* growth. 2. **Insufficient Critical Limits (21 CFR §123.6(c)(3)):** The HACCP plan's critical limits for "Receipt temperature" (41