FDA 483 - AUSTROFOOD S.A.S. - December 14, 2023

AUSTROFOOD S.A.S. in Quito, Ecuador, a human food manufacturer, received a Form 483 for significant deficiencies in its food safety plan and plant sanitation. Observations included a failure to identify heavy metal hazards in cinnamon, inadequate pasteurization monitoring, and a lack of preventive controls for physical hazards from damaged equipment. Additionally, the facility lacked proper backflow protection for water outlets.