FDA WARNING_LETTER - Big O' Smokehouse, Inc. - January 27, 2012

On January 23-27, 2012, the FDA inspected Big O’ Smokehouse, Inc. 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 vacuum-packed, air-packed smoked fish products, and smoked fish spread adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Inadequate HACCP Plan Implementation (21 CFR 123.6(b)):** Failure to record fish thickness, document storage critical control points daily/every three days, and monitor cooling critical limits on production reports. 2. **Incomplete Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The smoked fish HACCP plan did not identify pathogen growth and toxin formation (specifically *Staphylococcus aureus* during brining) and undeclared allergenic substances at packing/labeling. The smoked fish spread HACCP plan also omitted undeclared allergens. 3. **Missing Critical Control Points (21 CFR 123.6(a) and (c)(2)):** The smoked fish HACCP plan lacked a critical control point for "Thawing" to control pathogen growth, including *Clostridium botulinum*, especially