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American Cruise Lines was cited for serving adulterated potable water on its American Star and American Heritage cruise vessels, which contained Legionella pneumophila and other Legionella species detected in biofilm swabs and water samples. The violation stemmed from insanitary conditions in the potable water systems aboard both vessels that created risk of contamination and rendered the water injurious to health. The enforcement action followed three confirmed cases of Legionnaires' disease diagnosed in passengers who traveled on these vessels in April, September, and September-October 2021, prompting FDA investigations and inspections from December 2021 through August 2022.