LNZRO Pizza Empire, Inc. – FDA Warning Letter, May 18, 2018

On May 10 and 18, 2018, the FDA inspected LNZRO Pizza Empire, Inc.'s seafood processing and distribution facility, identifying serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render the firm's refrigerated, ready-to-eat canned crab meat and battered/breaded haddock adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to have and implement a HACCP plan for refrigerated, ready-to-eat canned crab meat to control *Clostridium botulinum* toxin formation (21 CFR 123.6(a) and (b)). The submitted revised HACCP plan for pasteurized canned crabmeat was inadequate, lacking sufficient critical limits, monitoring, and corrective action procedures. 2. Inappropriate corrective actions in the battered/breaded haddock HACCP plan at the "(b)(4)" and "(b)(4)" CCPs (21 CFR 123.7(b)). The corrective actions did not ensure the cause of deviation was corrected or how operational control would be regained. The revised HACCP plan for battered/breaded haddock did not adequately address these deficiencies. 3. Failure to review critical control point monitoring records within one week of creation (21