A.P. Bell Fish Company, Inc. – FDA Warning Letter, Feb 4, 2008

On June 4, 2008, the FDA issued a Warning Letter to A.P. Bell Fish Company, Inc. following an inspection on February 1 & 4, 2008. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The FDA found that the firm's scombrotoxin-forming species of fish were adulterated due to insanitary conditions. Significant violations included inadequate monitoring of sanitation conditions and practices, specifically regarding water safety (lack of back-flow prevention), cleanliness of food contact surfaces (filth, rust, peeling paint, chips, cracks, non-impervious materials), prevention of cross-contamination (ice shovels on floor, employees standing on product, raw fish returned to pile without rinsing, soiled gloves, damaged ice room doorway), maintenance of handwashing facilities (no soap/paper towels, filth), protection from adulterants (condensate dripping, crates on exposed product), storage of toxic chemicals (bleach in processing area), and exclusion of pests (birds in processing areas).

Furthermore, the firm's HACCP plan for "Finfish (w/histamines)" was deficient. It failed to list receiving as a critical control point for scombrotoxin for secondary processors, lacked appropriate critical limits for decomposition, and