Skip to content

US Food and Drug Administration (FDA)

Is your building registered with the FDA?

If you are thinking of starting to import food or pharmaceutical products into the United States, the first step is to register your foreign facility (factory or distribution center) with the FDA.

This registration is renewable every two (2) years. Once completed, your site obtains a worldwide unique registration number, to be entered in particular on your import documents.

GROUPE TRANSIT can take care of this registration for you.

Fee: $595.00 USD. Commissioning: 2-4 days. For Express (one (1) day, add $50.00 USD.

Includes: Company registration and FDA registration number

THE FSVP: FOREIGN SUPPLIER VERIFICATION PROGRAM

Since November 2017 – Following a judgment by the American Congress, the Food & Drug Administration (FDA) requires foreign manufacturers of food and cosmetic products to have a respondent on American soil who can become their FDA legal importer, the ‘FSVP Importer’.

In 2020, the FDA announced that it will intensify the pressure at the border, so much so that many buyers, wholesalers, banners and other large US prime contractors are already demanding that their foreign manufacturers comply quickly by finding another ‘FSVP Importer’ on US soil.

Don’t wait for this to happen to you. Be proactive! Make GROUPE TRANSIT your ‘FSVP Importer’.

What is FSVP: FDA Us Food and Drug Administration Logo

FSVP Intro Video

This short video explains how GROUPE TRANSIT intervenes with foreign manufacturers, regardless of their origin, so that they are able to import efficiently thanks to GROUPE TRANSIT‘s ‘FSVP Importer’ service and then deliver to customers.

FSVP IMPORT PACKAGES

GROUPE TRANSIT offers two easy options for foreign companies to represent them on US soil, acting as their ‘FSVP Importer’:

GLOBAL Passport:

  • Global coverage for one (1) year in all of your US markets
  • Unlimited number of imports

‘A LA CARTE’ Passport:

  • Piece coverage (per customs entry) for each of your shipments
  • Annual review.

Conditions:

The foreign manufacturer must first provide GROUPE TRANSIT with:

  1. A completed V001 registration form
  2. Copies of its food safety and security program by site*
  3. A copy of the last audit from a recognized international external firm

*This program must have international recognition.

US FOOD BROKER AND BANNER SERVICES

Special Program

With its team of specialists based in Rutland, VT, GROUPE TRANSIT offers various banners and food brokers in the United States to act as their ‘FSVP Importer’ with all their foreign manufacturers.

The banner or the broker thus detaches itself from this important responsibility of legal importer in the eyes of the FDA and allows it to focus its human and financial resources on what matters most, namely the profitability of its own operations.

FDA: LABELING AND NUTRITIONAL FACTORS

THE IMPORTANCE OF BEING COMPLIANT BEFORE SHIPPING

Once your site is registered with the FDA and the regulatory and customs verification has been carried out, this is the third step before you can ship your products to the United States.

Whether for a product launch, recipe modification or introduction to the American market, Groupe Transit can help with it’s preparation and/or revision service in order to ensure you comply with FDA regulatory requirements, which are numerous and unavoidable.

FLEXIBLE SERVICES

  • Verification of label conformity and packaging
  • Validation of the list of ingredients
  • Development of Nutrition Facts tables
  • Verification or proposal of allegations (claims)
  • Regulatory advisory service

PROVEN EXPERTISE

Our multidisciplinary team has the expertise to provide you with recommendations on a wide range of foods according to FDA rules.

  • All types of food and beverages
  • Niche products
  • Shipping container
  • Meat products
    • Verification if the product qualifies for generic approval
    • Request USDA approval for products that require it
en_USEN