Also, once on a Red List Import Alert, in which specific firms from certain countries have a pattern of non-compliance, any future products imported from these firms will be detained without physical examination (DWPE) until it can be shown that they are safe and meet pre-approved standards.
Moreover, foreign manufacturers of regulated products who refuse to permit or delay FDA establishment inspection may be subjected to DWPE.
Finally, if the FDA has documented an importer’s practice of repeatedly offering violative articles for importation and attempting to recondition these shipments only after FDA detention, or of repeatedly attempting to export shipments or withdraw entries after receiving a notice of sampling or other indication of interest (inquiries regarding product location), DWPE would be recommended covering either specific commodities or all regulated products offered for entry by that importer.
The agency’s decision to remove a product, manufacturer, packer, shipper, grower, country, or importer from DWPE should be based on evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and the FDA has confidence that future entries will be in compliance with the FD&C Act.
The compliance officer can issue a refusal of admission if FDA does not receive a response by the “respond by” date listed on the Notice of FDA Action.
Typically, the “respond by” date is 10 business days but can be up to 20 calendar days to allow for weekends, holidays, and mailing time.
When you are unable to overcome the appearance of a violation, your product will be refused admission and you can work with U.S. Customs and Border Protection (CBP) and FDA to destroy the product or export it from the U.S within 90 days of the refusal.
U.S. Agents can always help. Some are better at it than others. ITB HOLDINGS LLC is one of them. Keep that in mind.
The most common problem is delay in contacting a U.S. Agent soon enough when FDA Notice is received, resulting in insufficient time to assemble all the evidence and triggering a panicked request for an extension.
Indicate exactly what you have found out from the FDA in order to determine how to clear your product. It is critical that the correct steps are taken when sampling and testing or the data will be rejected.
Count on U.S. Agents to walk you through the process, and stop worrying.
Also, remember that FedEx, UPS, DHL and other companies will not be able to provide the much needed assistance.