FDA WARNING_LETTER - Blum's Spring Lake Fisheries - May 26, 2010

On October 14, 2010, the FDA issued a Warning Letter to Blum’s Spring Lake Fisheries following inspections on April 26 and May 26, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), Current Good Manufacturing Practice (21 CFR Part 110), and Food Labeling (21 CFR Part 100).

Key violations include: - **HACCP Plan Deficiencies:** Failure to have HACCP plans for smoked salmon (pathogen growth/toxin formation, pathogen survival) and ready-to-eat raw buffalo fish eggs (pathogen growth/toxin formation). The HACCP plan for smoked fish lacked critical control points for the brine step and refrigerated storage. - **Monitoring Failures:** Inadequate monitoring procedures, specifically a discrepancy in temperature readings for a temperature recorder (chart recorder showed 210°F, digital read-out 165°F, calibrated thermometer 169°F). Intermittent temperature checks for refrigerated storage were deemed insufficient. - **Sanitation Violations:** Insufficient monitoring of sanitation conditions, evidenced by residue buildup on smoker racks not cleaned between batches. Environmental issues included unused equipment creating pest harborage, gaps in the processing building door allowing pest ingress, and apparent nesting material/droppings in the smokehouse. Sanitation