FDA registration number is a unique identifier assigned by the US Food and Drug Administration (FDA) to facilities that manufacture, process, pack, or store food, drugs, medical devices, or cosmetics intended for consumption or use in the United States.
The FDA registration number is used to identify registered facilities and track products manufactured or distributed by those facilities. It is also used to ensure that facilities are in compliance with FDA regulations and can be inspected by the FDA as necessary.
How to get an FDA registration number?
To obtain an FDA registration number, you must register your facility with the FDA. You must provide information such as your facility’s name, address, emergency contact information, and the type of products you manufacture or store.
For a food facility once you have registered your facility with the FDA, you will be assigned an eleven-digit FDA registration number. This number must be renewed every even-numbered year, and any changes to your facility or the products you manufacture must be reported to the FDA in a timely manner. for drug and medical device establishments, the renewal must be done every year between October 1 and December 31.
It’s important to note that obtaining an FDA registration number does not necessarily mean that your products are FDA-approved or that your facility is in compliance with FDA regulations. It indicates that your facility is registered with the FDA and has met the initial requirements.
To search for an FDA registration number for a medical device or drug establishment, you can use the FDA’s registration and listing database, publicly available on the FDA website.
Steps to search for an FDA registration number:
- Go to the FDA’s registration and listing database website
- Choose the search option you prefer – you can search by facility name, registration number, or FDA establishment identifier (FEI).
- Enter the search criteria in the appropriate field.
- Click on the “Search” button.
The search results will appear on the screen. If the registration number you’re searching for is valid and active, the search results should include the name and address of the facility, as well as information about the products it manufactures, processes, packs, or holds.
FDA Registration number for a food facility
FDA registration numbers for food facilities are confidential; you cannot search for them on the FDA website.