FDA MEDDLING WITH IMPORT ALERTS (NOT GOOD)

fines

From:  FDAImports.com and Ben England

Look out, industry: there’s a new way to get put on Import Alert.  FDA is beginning to place firms on import alert based on traceability data collected by FDA and the Center for Disease Control and Prevention (CDC).  Firms used to think they would only end up on import alert if testing revealed violations in the product; that is no longer the case.

After reviewing the traceability reports of some multi-state foodborne outbreaks, FDA determined that future product imported by the involved firms appears adulterated. These firms were added to import alert based solely on traceability data and epidemiological investigation reports.

When FDA places a firm’s product on import alert, it begins to automatically detain shipments of that product from that firm.  FDA then requires the U.S. importer to prove the product compliant, which may require laboratory testing; otherwise, FDA refuses the product.  FDA has the authority to refuse any product that “appears” violative – and there are many, many things which can make a product “appear” violative, such as a blemish on an importer or manufacturer’s import history.  Any FDA staff or unit can recommend a firm or product for import alert – or for removal from Import Alert – when it believes that such action is warranted.

Traceability Reports linked to Outbreaks can Land you on Import Alert

Firms can now end up on import alert if traceability reports reveal that their products are linked to an outbreak.  The recent outbreaks (cucumbers, pomegranate seeds, cantaloupes, etc.) have already resulted in Import Alert listings for some firms.

The best way to avoid this kind of import alert listing is to strictly assure the quality of raw material supplies and suppliers.  Importers should verify the safety and compliance of their imported products with their manufacturers.  By instituting these verification procedures, you can avoid the complications and expense caused by FDA automatic detention and refusals.  

 

 

Leave a Reply