FDA Creates New Import Alert on Lack of Preventive Controls for Ready-to-Eat Foods

FDA has created a new import alert for ready-to-eat human foods that don’t meet the agency’s preventive controls regulation requirements. New Import Alert 99-43 published Nov. 13 provides for detention without physical examination of “Ready-To-Eat Human Food Products That Appear To Have Been Prepared, Packed, Or Held Under Insanitary Conditions,” its title says.

The import alert addresses ready-to-eat human foods “where FDA has evidence that a firm's lack of or inadequate preventive controls or inadequate [good manufacturing practices (GMPs)] has led to adulteration of the food products,” and where those findings may “necessitate the need for documentation demonstrating corrective actions” or analytical results “to overcome the appearance of adulteration,” FDA said.

As of Nov. 16, no firms have been added to the import alert. Reasons for addition to the import alert may include multiple violative samples of ready-to-eat food products from an individual manufacturer, which may lead to all food from that manufacturer being added to the new import alert’s “Red List” if the samples cover multiple food products. FDA may also add manufacturers based on inspectional evidence of inadequate controls, and trace-back evidence implicating a food product as a vehicle in a food-borne illness outbreak.

The alert also provides information to firms subject to detention without physical examination regarding “documentation they should provide to be considered for removal.” That evidence may include documentation “of a root cause analysis,” a written food safety plan, and documentation that any issues identified by FDA have been corrected.