FDA requires US and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the USA to register with FDA.
Important definitions:
- Facility – any establishment, structure, or structures under one ownership at one general physical location that manufactures, processes, packs, or holds food for consumption in the USA.
- Domestic facility – any facility located in the USA, the District of Columbia, or the Commonwealth of Puerto Rico that manufactures, processes, packs, or holds food for consumption in the USA.
- Foreign facility – any facility other than a domestic facility that manufactures/processes, packs, or holds food for consumption in the USA.
- Manufacturing/processing – making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients.
- Holding – storage of food and includes activities performed incidental to storage of a food. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
- Packaging – placing food into a container that is directly in contact with the food.
- Packing – placing food into a container other than packaging the food and includes re-packing and activities performed incidental to packing or re-packing a food.
- Trade name – other names under which the facility conducts business or is known by.
- US Agent – person residing or maintaining a place of business in the USA and who is designated as agent by a foreign facility.
- The US Agent acts as a communications link between FDA and the foreign facility for both emergency and routine communications. The US Agent will be the person FDA contacts when an emergency occurs, unless the registration specifies another emergency contact.
- FDA will consider the US Agent the equivalent of the registrant for purposes of sharing information and communications.
- Registrant – the owner, operator, or agent in charge of a facility that manufactures, processes, packs, or holds food for consumption in the USA.
Liberty Management Group Ltd. can help you with FDA registration & US Agent service.
Namrata
Regulatory Consultant