FDA 483 - Hornblower cruises and Events LLC - September 30, 2025

An FDA inspection conducted from September 26-30, 2025, at a vessel servicing facility in New York, NY, responsible for potable water and lavatory waste services, revealed numerous significant deficiencies. Many of these issues were repeat observations from previous inspections. The primary concerns centered on maintaining the integrity and proper management of potable and non-potable water systems, as well as overall sanitation practices. Major violations included a widespread absence of backflow prevention devices on critical water lines, posing a considerable risk of contamination. The facility also failed to adequately distinguish between potable and non-potable water hydrants, hoses, and outlets, which could lead to cross-contamination. Specific instances highlighted non-potable hoses being used for potable water bunkering, unlabelled potable water hoses, and non-potable hydrants lacking clear "UNFIT FOR DRINKING" signs. Additionally, essential records for the annual testing of backflow prevention devices and for the cleaning and disinfection of vessel potable water systems were not available. Further issues involved improper storage of a sewage hose, which was observed submerged in river water, and an unlabelled potable water filling connection panel on a passenger vessel. These observations indicate a systemic failure to adhere to sanitation standards designed to prevent the introduction or spread of communicable diseases, falling under the regulatory purview of the Federal Food, Drug and Cosmetic Act. The firm is expected to undertake comprehensive and prompt corrective actions to rectify these recurring issues and ensure the safety and purity of water services.