FDA WARNING_LETTER - Chloe Foods Corp - May 30, 2008

The FDA inspected Chloe Foods Corp.'s seafood processing facility in Brooklyn, NY, from May 13-30, 2008, and found serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. These violations render their refrigerated, ready-to-eat seafood salads, like "Krab Salad" and "Neptune Salad," adulterated.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for refrigerated ready-to-eat seafood products failed to list pathogen growth and toxin formation as a food safety hazard at the "receiving processed seafood/fish items" critical control point, despite having a procedure for temperature checks. 2. **Missing Critical Control Points (21 CFR 123.6(c)(2)):** The HACCP plan did not include in-process storage of histamine species (e.g., tuna salad) as a critical control point with appropriate limits and monitoring. 3. **Inadequate Sanitation Monitoring (21 CFR 123.11(b)):** The firm failed to adequately monitor the prevention of cross-contamination and the cleanliness of food contact surfaces. Examples included old product residues on automated fill lines and pumps, food residues in dent