An Import Alert allows FDA to detain, without physical examination, products that either have or potentially could violate the Food, Drug, and Cosmetic Act (“FDC Act”). Import Alerts lets FDA Field Staff know that the agency has enough evidence or other information to refuse admission of future shipments of an imported article. There are a variety of factors that could lead FDA to place a product, manufacturer, shipper, grower, geographical area, and/or country on Import Alert.
Once a shipment is refused admission to the U.S., the importer has an opportunity to introduce evidence, within 10 days, to overcome the appearance of a violation. During this time, the product is either held at a warehouse or at the importer’s premises and cannot be distributed. If the shipment is not proven to be safe, it must be destroyed or exported within 90 days.
The alert can be issued for an import from a manufacturer, shipper, grower, geographical area, or country. If the problem or condition exists on a wide scale, federal inspectors would be instructed to detain all products of a certain kind coming from that country.
An imported product, firm, region, or country may remain in this status until evidence or other information is provided that gives FDA confidence that the shipment is safe for consumers and that future shipments will be in compliance with the law. The conditions that the importer has to meet vary depending on the stipulations in the Import Alert.
This webinar will provide attendees with background about FDA Import Alerts, examine why they are issues, where to locate them, how to find whether a company or product is the subject of an Import Alert, and finally, provide a series of strategic recommendations for getting off of an Alert.
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