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“We highly recommend Joe Shipping and Logistics for anyone looking for a reliable and knowledgeable partner to arrange imports.
They always go the extra mile to make sure that the import shipments go smoothly and the equipment gets delivered to our clients.
They are experts in customs regulations and procedures, and they help us avoid any delays or penalties.
They are the best in the industry!
Dairy Technology USA”
Food and Drug Administration Filing
U.S. Customs and Border Patrol (CBP) requires that all products entering the United States be declared. That means that all goods being brought into the U.S. must be detailed beforehand to ensure compliance with U.S. laws and regulations.
The CBP works alongside agencies like the U.S. Food and Drug Administration (FDA) to ensure that products brought into the U.S. are safe and as declared. Food, cosmetics, pharmaceuticals, and medical devices all must be approved and be made from approved ingredients or materials. These products must also conform to laws and regulations relating to their labeling.
Because there are very strict laws and regulations relating to products that require FDA approval, it is wise to work with a customs brokerage service. At Joe Shipping & Logistics, we can help you prepare documentation and respond to any requests for additional documentation or verification.
How an FDA Filing Works
To begin the import process, the importer or customs broker must submit the required customs details. The CBP then forwards the information to the FDA. The FDA will then request additional information or documents, or will approve the import. It is very common for the FDA to request additional documentation to ensure compliance.
While this process can be complicated and can take time, working with Joe Shipping & Logistics can streamline and simplify the process so you can focus on your business. We can help you complete your FDA filing step-by-step, including the following:
- Register with the FDA: Importers and receiving facilities in the exporting and importing locations must register.
- Entry Identifier: The FDA will assign a seven-digit identifier that you will use for FDA Prior Notice.
- FDA Product Code: Find the FDA product code, which describes the product or group. If you aren’t sure, we can help you find it in the FDA database.
- File FDA Prior Notice: Once your registration is complete, you can file FDA Prior Notice before shipping.
- Provide Information to the FDA: The FDA requires certain information during the customs clearance process. You may be asked to provide the following:
- FDA product code
- FDA manufacturer code
- FDA supplier code (if provided by the supplier)
- Importer Federal Establishment Identifier (FEI)
- FDA shipper number (your shipper will supply this)
- Manufacturer Processor FDA number (the manufacturer will supply this)
Once you have completed the FDA filing, your goods will undergo an FDA exam. The FDA may then request additional information, will process paperwork, and then will release your shipment. In some cases, they require a physical exam of the goods.
Get Help with Your FDA Filing
Importing a product that is regulated by the FDA can be complicated. It is a process that is most successful when managed by a professional customs brokerage service. To get help with your FDA filing, contact Joe Shipping & Logistics. Or, get a free quote online.