As part of the registration of the foreign manufacturer is the identification of who will be receiving the company’s product for sale in the US. This is the the Initial Importer. This may be a company that wants to sell your product (distributor) or an Initial Importer who is simply your FDA registered Initial Importer for the warehousing and shipping of your product.
Marketing in the US is a daunting task and will normally take many different avenues to sales, through regional distributors, independent sales rep, etc. The initial importer is your central receiving warehouse freeing the foreign company to engage as many different distributors as you wish for sales without requiring these various sales entities from registering with the FDA. The Initial Importer must be compliant to QS Part 820 for their services, registered with the FDA and also available for FDA inspections. Most distributors want none of this FDA involvement in their companies and look to the initial importer to take on that service. Another aspect of our service is complaint handling, which is FDA’s compliance branch hot buttons.