The Food and Drug Administration (FDA) requires registration of manufacturing warehousing facilities for most product categories under the agency’s jurisdiction. This is true for food, dietary supplement, pet food, animal feed, drug, medical device, and biologic facilities. The only exception is the cosmetic sector; registration is voluntary for cosmetics. Facilities located outside the United States must have a U.S. Agent that is located in the U.S. to act as a liaison between FDA and the facility. All required registrations must be renewed or updated before the end of the year.
Food Facilities
Food, Dietary Supplement, Pet Food, & Animal Feed Facilities are classified as ‘food’ facilities and must renew their registration between October 1st and December 31st of even-numbered years. 2022 is a renewal year and as of today, only a few weeks remain to complete the registration process. Fortunately, the process can be readily accomplished online. There is no cost for food facility registration.
Registration is required so that FDA can be aware of the location and source of potential outbreaks of foodborne illness or other incidents that could affect public health. Facilities located outside the United States must have a U.S. Agent that is located in the U.S. to act as a liaison between FDA and the facility.
FDA has published a step by step user guide to the registration process. In addition to expected queries about the facility’s name, location, and management, two very important bits of information are required for registration:
- A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act;
- A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate.
These two requirements ensure that FDA will have cause and authority to cancel a facility’s registration if the agency is denied access to the facility or if there is a finding that the information submitted was incorrect.
Drug, Medical Device, & Biologic Facilities
Other FDA-regulated facilities must also be registered. The drug and medical device sectors must also ‘list’ their products.
Drug Companies must update their listing of product twice each year, in June and December. A quick guide to drug facility registration can be found here.
Like drug companies, Medical Device companies must register their facility and list their products. Device registrations and listing must be updated annually. Foreign facilities must have a US Agent to complete the registration process.
Biologic Facility Registration must be updated annually between November 15th and December 31st. The system for registration and listing for biologic products varies by product type. The drug registration system is used for vaccines while blood and tissue products have separate registration and listing systems.
We hope that most of you do not need this reminder and that your company is up to date and looking ahead to 2023. Let us know if you need help with facility registrations or other aspects of compliance with FDA regulations.
