FDA 483 - Sucden Americas Corp - March 31, 2025

Sudden Americas Corp in Miami, FL, was inspected regarding its Foreign Supplier Verification Program (FSVP). The inspection revealed significant deficiencies, including a lack of established written procedures for foreign supplier verification activities and insufficient documentation of verification activity frequency. Additionally, the firm's hazard analysis failed to identify a required hazard, indicating a need for improved controls over imported food safety.