Food Facilities are:
- Processors, Packers
- Exporters, Importers, Distributors
The FDA regulates approximately 80 percent of the foods Americans eat, including seafood, fresh fruits and vegetables, milk and dairy products, baby food and infant formula, frozen, canned, packaged and snack foods, juice, soft drinks and much more.
Therefore, manufacturers, exporters and importers are required to register their facilities, and provide adequate assurances that these products meet applicable U.S. food safety standards.
Retail food establishments (grocery stores, restaurants, cafeterias, and food trucks), as well as farmers markets, are examples of food businesses not regulated by the FDA.
Please make sure to obtain a DUNS Number, which is required.
Also, waiting until the last minute to renew your Food Facility Registration (FFR) is never recommended, as more than 222,000 domestic and foreign companies will start processing their registrations on October 1, 2022.
- Medical Devices Establishments
- Prescription Drugs Establishments
- Over-the-Counter (OTC) Drugs Establishments
- Over-the-Counter (OTC) Cosmetics Establishments
Which company must be registered, and is required to renew its registration
All contract manufacturers and sterilizers of finished medical devices must register and list regardless of whether they put the device into commercial distribution or return the device to the manufacturer or specification developer.
Foreign establishments that are exporting medical devices or offering them for export to the United States, must identify all known U.S. importers of their devices.
A medical device must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer, or repacker/relabeler before a foreign exporter, contract manufacturer, or contract sterilizer can list it.
Initial Importers must identify the manufacturers of the devices they are importing.
Establishments located in foreign trade zones must now register and list, as well as identify themselves as being located in a foreign trade zone.
Any establishment engaged in manufacturing, repacking, relabeling or salvaging drug products for U.S. distribution is required to register with FDA, and renew its registration annually. There are some exceptions.
Annual registration renewal must occur between October 1 and December 31 each year.
Check the status of your registration at the Drug Establishment Current Registration Site (DECRS).
The top five countries by number of drug manufacturing sites in the Fiscal Year 2020 were the United States, India, China, Germany, and Canada.
If your company manufactures, exports, imports, distributes Hand Sanitizers, Wet Wipes, Fluoride Toothpaste, Antiperspirants, Dandruff Shampoos, Sunscreens, among many other over-the-counter (OTC) products, then you should get ready for your Annual Registration Renewal.
U.S. Agent Requirement
Unlike U.S. domestic companies, foreign establishments are required to designate and maintain a U.S. Agent for the purpose of FDA registration.
Annual or Biennial Registration Renewal is your perfect opportunity to switch U.S. Agent.