FDA WARNING_LETTER - Flagship Niagara League Inc. - July 19, 2010

On August 25, 2010, the FDA issued a Warning Letter to Flagship Niagara League, Inc. following an outbreak of Salmonella serotype Enteritidis (SE) in July 2010, linked to food served on their passenger vessel, Flagship Niagara. The outbreak was reported by Erie County Department of Health officials after individuals became ill from consuming food items, including Mexican chicken dinner and macaroni salad, on board the vessel near Cleveland, OH.

Subsequently, FDA conducted an inspection of the vessel on July 17 and 19, 2010, under the authority of the Public Health Service Act (PHS Act) and the Interstate Conveyance Sanitation regulations (21 CFR Part 1250). The inspection revealed significant deviations from 21 CFR Part 1250, documented on Form FDA-483.

Key violations included: 1. Lack of hot water at adequate temperatures in food preparation and utensil cleaning areas (21 CFR 1250.30(c)). 2. Absence of a thermometer in the warmest portion of the galley's reach-in refrigerator (21 CFR 1250.34). 3. Improper storage of clean utensils (pots and pans) on the galley floor, leading to potential contamination (21 CFR 1250.33(c)).

The FDA emphasized that these were