Louis Morales dba H&H Seafood – FDA Warning Letter, Sep 13, 2012

On September 10-13, 2012, the FDA inspected H & H Seafood Company in Houston, Texas, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render the firm's fresh scombroid species, refrigerated ready-to-eat crabmeat, and pasteurized canned crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(1)):** The firm's sole HACCP plan fails to list critical food safety hazards such as histamine formation for fresh scombroid species (mahi-mahi, tuna), *Clostridium botulinum* for pasteurized canned crabmeat, and pathogen growth/toxin formation for refrigerated ready-to-eat crabmeat. Additionally, the plan improperly groups products with different food safety hazards. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan's critical limits at receiving and storage CCPs for pasteurized canned and refrigerated ready-to-eat crabmeat are insufficient to control pathogen growth and toxin formation, including *Clostridium botulinum*. Similarly, critical limits for