FDA REGISTRATION NUMBER
● Companies can export or import Food Products, Dietary Supplements | Dietary Ingredients to or from the United States as long as the facilities that produce, store, or otherwise handle the products are registered with the FDA (Food and Drug Administration), and prior notice of incoming shipments is provided to the FDA.
● Offering an article that is a drug or medical device for import without establishment registration, is illegal.
● Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA.
● Any representation in labeling or advertising that creates an impression of official approval because of registration or possession of a registration number is considered misleading.
● The facilities or establishments of both the exporter and the importer are required to register, and obtain an FDA REGISTRATION NUMBER.
Beginning October 1, 2020, FDA will not confirm a registration, provide a registration number, or provide confirmation of a registration renewal until it verifies the accuracy of your facility’s unique facility identifier (UFI) and that the facility-specific address associated with the UFI is the same address associated with your registration.
FDA recognizes the Data Universal Numbering System, D-U-N-S (DUNS) number, as an acceptable UFI.
Include the following:
● Name of CEO / Manager
● Company name
● Company address
● Company telephone
● Product details
$198.00 | Food or Supplements Facilities
$99.00 | Food or Supplements Facilities
SEE BELOW FOR OTHER FDA REGULATED PRODUCTS
■ You make your request by email
■ You pay our invoice
■ You sit back and relax
■ You get your company's file and
■ FDA REGISTRATION NUMBER
■ Your current or new FDA REGISTRATION must be renewed between October 1 and December 31, 2020.
■ Startups like yours
■ Companies switching U.S. Agent
■ Foreign companies, mostly
Compliance is enforced. Foreign companies do not need to take a chance.
Monday - Sunday
3:00 AM - 6:00 PM
Eastern Standard Time
■ Facilities that manufacture, process, pack, or hold food contact substances, including food packaging or bottled water containers or closures, are not required to register.
■ A retail food establishment is exempt from registration if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers.
■ Supermarkets are exempt from registration as “retail food establishments” if the primary function is to sell food products directly to consumers.
■ Distribution centers or warehouses that are not at the same general physical location as retail food establishments do not meet the definition of "retail food establishments".
■ Central kitchens that do not sell the food they prepare directly to consumers for immediate consumption are not “restaurants”, and must have a REGISTRATION NUMBER.
■ A private residence from which a person also sells food through the Internet is not a “facility” and, thus, would not have to register.
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From warehousing to pick and pack services, with established systems to ship and track orders to retailers and consumers.
They offer web-based Fulfillment Control Panel (FCP), and the ability to monitor orders in real time and keep track of the level of inventory, from anywhere in the world.
You pay only for the service you use, and there are no long-term commitments.
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