FDA WARNING_LETTER - American Cruise Lines Inc - American Constellation - June 17, 2022

The FDA issued a Warning Letter to American Cruise Lines following investigations and inspections of their American Star and American Heritage vessels from April to August 2022, prompted by three passengers diagnosed with Legionnaires’ disease in 2021. Laboratory analysis of samples from both vessels identified Legionella pneumophilia serogroup 1 and Legionella spp. in the potable water systems.

The FDA determined the potable water on both vessels was adulterated under sections 402(a)(4) and 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, due to insanitary conditions and the presence of a deleterious substance (Legionella).

Key violations included: - **Presence of Legionella:** Widespread detection in biofilm swabs and potable water samples from various locations, including passenger cabins, crew rooms, and galley areas. - **Inadequate Post-Notification Actions:** Failure to change procedures for flushing, disinfection, or environmental sampling after initial CDC notifications of Legionnaires’ cases. Subsequent disinfection efforts were deemed insufficient, and follow-up testing was criticized for limited scope and sensitivity. - **Failure to Monitor Potable Water Parameters:** Lack of consistent monitoring for free/total chlorine residual, temperature, and pH, leading to conditions ideal for Legionella growth (e.g., low chlorine, warm temperatures, stagnant water). - **Failure to Monitor Disinfection Effectiveness:** Disinfection procedures lacked verification of disinfectant levels, pH, and