The Food and Drug Administration (FDA) has recently increased the amount of scrutiny put on imported goods. This has impacted our industry most through additional attention placed on the validity of vineyard FDA numbers. Unfortunately, Elenteny Imports is not allowed to verify vineyard FDA numbers. It is only after a shipment is submitted for custom clearance that we are notified of any issues related to a vineyard’s FDA number. To help us process your shipments without any delays, or additional costs we ask the following:
- Please ensure that all FDA numbers are validated by either the vineyard or the registered US FDA agent by contacting the FDA help desk at 1-888-463-6332.
- Please note that any discrepancies or issues could result in additional demurrage storage charges until the issue is resolved.
- Be aware that all FDA numbers will be cancelled on December 31, 2020 unless verified through the FDA portal in the three months prior.
For more information please see the notification below from the U.S. Customs and Boarder Protection agency. If you have any specific questions, please reach out to your account representative, or contact us at firstname.lastname@example.org.
We thank you for your support and help with this situation.
The Elenteny Imports Team
Foreign Supplier Program Violations
The Food and Drug Administration continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program. The FSVP requires importers to perform certain risk-based activities to verify that the human and/or animal food they import has been produced in a manner that meets applicable U.S. food safety standards. In the latest case, two FDA inspections of the importer’s facility found that the importer did not have the required plans for fried onions, basmati rice, and other products. The FDA states that within 15 working days the importer should provide information on the specific things it is doing to correct these violations; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importer does not act promptly the FDA may take further action, such as refusing admission of the violative products and subjecting them to detention without physical examination.
Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert. Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers. Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance. If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.