FDA issues an import alert when they have enough evidence to believe that certain imported products, firms, or country areas are not in compliance to FDA regulations.
Import Alert informs FDA field staff, importers as well as the general public that specific products or companies appear to be in violation of FD&C Act and authorizes detention of all future shipments automatically instead of examining or sampling the shipments first (DWPE).
Foreign manufacturers and importers will need to provide sufficient evidence that the product is compliant before FDA removes the product/company from the list.
FDA generally issues import alert based on the non-compliance history of the firm or products, such as misbranding, unapproved ingredients, issues etc. This information can be obtained from prior shipment refusals and inspection records.
Firms and products that are added to FDA red list are impacted by storage and testing costs, shipment delays and refusals.
Liberty Management Group Ltd has a free online tool for its customers which actively detects import alerts and informs timely avoiding supply chain disruptions. This tool is available for all our clients. If a firm gets added to FDA import alerts, LMG quickly notifies the respective firm so that timely and precautionary measures are taken.
Namrata
Regulatory Consultant
support@libertymanagement.us