FDA 483 - DEMOBREAD INC dba FIRST HARVEST - February 07, 2025

This FDA Form 483 was issued to DEMOBREAD INC dba FIRST HARVEST in Boca Raton, FL, following an inspection of their Foreign Supplier Verification Program. The inspection revealed significant deficiencies, primarily a lack of written procedures for hazard analysis, foreign supplier evaluation, and foreign supplier approval and verification activities for imported food products. These observations indicate a failure to establish and implement a compliant FSVP.