The U.S. Food and Drug Administration (FDA) recently placed additional firms on Import Alert 89-08 on charges of adulteration or misbranding. Products added to the Import Alert include COVID-19 testing kits, personal protective masks, dermabrasion devices, and infrared thermometers, among others. FDA has determined these products lack either a 510(k), Pre-Market Approval (PMA), or an Investigational Device Exemption (IDE), as required for commercial distribution.

Checking to see if your supplier is on this Import Alert? Keep reading to learn how you can continually track your suppliers’ compliance.

Import Alerts

When FDA places a firm on an Import Alert red list, all shipments of the red listed product(s) from that supplier into the U.S. are subject to Detention Without Physical Examination (DWPE). Firms affected by Import Alert 89-08 are included on the red list, which indicates that FDA has noticed a pattern of non-compliance from the firms. By implementing DWPE, FDA helps to prevent certain non-compliant products that are being shipped to the U.S. from entering the market.

One of the reasons FDA implements Import Alerts is to “place the responsibility back on the importer to ensure that the products being imported into the United States are in compliance with the FDA’s laws and regulations.” The Foreign Supplier Verification Program (FSVP) Rule places the responsibility on importers to only import from suppliers that are FDA-compliant.

If a company is attempting to import supplies that are on an Import Alert, FDA will hold the importer responsible for failing to ensure their supplier was compliant. Importers are responsible for keeping track of FDA enforcement actions taken against their suppliers, including whether any of their suppliers are on an Import Alert list. If a supplier falls out of compliance, the importer must find a compliant supplier for the affected product.

Monitoring Suppliers

Suppliers may be added to FDA’s Import Alert lists without their importer’s knowledge. To avoid importing from a non-compliant company, you must continually monitor your suppliers. Registrar Corp’s FDA Compliance Monitor helps you automate compliance monitoring to easily identify vulnerabilities in your supply chain.

The Monitor is a digital platform that checks suppliers against six FDA databases daily. If FDA has taken enforcement action against one of your suppliers, you will be automatically notified. Unlike other methods that alert you later in the process when it might be too late to prevent FDA from taking enforcement action against your company, the Monitor alerts you in real-time so you can quickly change suppliers when necessary.