FDA 483 - CANELS USA LLC 12 - April 14, 2025

An FDA inspection of CANEL'S USA, LLC in Houston, TX, revealed a significant deficiency in their Foreign Supplier Verification Program (FSVP). The firm failed to document their review and assessment of hazard analyses conducted by foreign suppliers, specifically for imported candies. Additionally, they lacked documentation confirming that these hazard analyses were performed by qualified individuals, indicating a critical gap in ensuring the safety of their imported products.