FDA 483 - HARIBO FOOD 2004 INC - September 12, 2025

Haribo Food 2004 Inc. in Hialeah, FL, was inspected regarding its Foreign Supplier Verification Program (FSVP). The inspection revealed eight observations, many of which were repeat findings, indicating significant deficiencies in developing, implementing, and documenting their FSVP, hazard analyses, supplier evaluations, and verification activities for imported foods like cassava, mango, and coconut products. The severity is high due to the systemic and repeated nature of the violations concerning food safety and foreign supplier oversight.