FDA 483 - National Railroad Passenger Corporation (Amtrak) - September 03, 2025
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During an inspection conducted from August 18 to September 3, 2025, the Food and Drug Administration issued a Form FDA 483 to the National Railroad Passenger Corporation (AMTRAK). The inspection revealed a significant observation concerning personnel practices related to food safety within a cafe car. Specifically, an FDA investigator observed an attendant in cafe car 43372 on August 18, 2025. The attendant was found to be seated and engaged with a cell phone, while the required temperature log for food items remained empty. Amtrak's own guidance mandates that attendants prioritize checking and logging temperatures immediately upon boarding a train. When questioned, the attendant confirmed that this critical task had not been completed. This observation indicates a failure to implement reasonable measures or precautions to ensure proper food handling and safety protocols are followed by personnel. The issuance of the FDA 483 is a communication of objectionable conditions observed during the inspection, pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act. In response to this finding, Amtrak is expected to address the observation by discussing any objections, or by implementing and submitting details of corrective actions to the FDA. Such actions are crucial to ensure compliance with food safety regulations and to prevent potential health risks associated with improperly handled food.
- Inspection Date
- September 3, 2025
- Product Type
- Devices
- Person
ID · 39353c98-0092-439b-b802-7931cc3b7c3e