FDA WARNING_LETTER - Sea Fare Foods, Inc. - September 30, 2011

On October 24, 2011, the FDA issued a Warning Letter to Sea Fare Foods, Inc. following an inspection from September 12-30, 2011. The inspection revealed serious violations of the Fish and Fishery Products Regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110).

The FDA determined that Sea Fare Foods' hot smoked, vacuum-packaged, refrigerated fish products were adulterated because they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Inadequate Hazard Analysis and HACCP Plans (21 CFR 123.6(a) and (c)(1)):** * HACCP plans for refrigerated, vacuum-packaged, cooked, ready-to-eat, hot smoked whitefish, sable, salmon, and trout did not list *Clostridium botulinum* as a food safety hazard. * The HACCP plan for refrigerated, vacuum-packaged, cooked, ready-to-eat, hot smoked herring did not list *Clostridium botulinum* and Scombrotoxin (Histamine) formation. * The HACCP plan for "Pickled Ocean Herring in glass jars" did not list allergens, specifically milk. 2. **Insufficient Monitoring of Sanitation Conditions (21 CFR 123.11