FDA 483 - The Folger Coffee Company - March 12, 2025

The FDA conducted inspections at two facilities from February to March 2025, identifying significant compliance issues.

1. **The Folger Coffee Company** in Orrville, OH, was inspected from February 3 to March 12, 2025. The primary violation observed was the absence of a written hazard analysis for raw coffee beans imported from a foreign supplier. This issue falls under the Foreign Supplier Verification Program (FSVP) requirements as per Section 805 of the Federal Food, Drug, and Cosmetic Act. The company is required to develop and implement a comprehensive hazard analysis to ensure compliance.

2. **American Airlines, Inc.** at John F. Kennedy International Airport, Jamaica, NY, was inspected from March 6 to March 13, 2025. The inspection revealed several sanitary violations in the airline's watering point and lavatory services. Key issues included the lack of a testable backflow preventer, absence of hot water in handwashing stations, uncovered trash receptacles, and improper labeling of non-potable water hoses. Additionally, the facility had structural issues like uneven floors and leaking valves, which could lead to contamination. These observations, some of which were repeat violations from previous inspections, indicate a failure to maintain sanitary conditions as required by FDA regulations. The airline must address these deficiencies to prevent the spread of communicable diseases and ensure the safety of its operations.

Both companies are urged to take corrective actions promptly to address these violations and ensure compliance with FDA regulations.