Frequently Asked Question (FAQ)
What is the FDA And what do they do?
The United States Food and Drug Administration (FDA) is U.S government agency put in place to regulate a variety of product categories including Food, Drugs, Medical Devices and Cosmetics. Their regulations on these products are intended to protect the American people from anything harmful that these products may contain.
What is a Foreign/Domestic Food Facility Registration? And what is its purpose?
A Foreign/Domestic Food Facility Registration is a registration required by the United States Food and Drug Administration in accordance to the Food Modernization Act signed into law in 2011. The Foreign/Domestic Food Facility was put in place due to the rise of food borne ilnesses and deaths relating to food borne ilnesses. This registration is needed for any one looking to import and sell Human or Animal Food, Food Additives, or color additives. Contact us to assist you register your domestic/foreign food facility.
What is a UFI? Why is it needed for a Food Facility Registration?
UFI is the Unique Facility Indentifier. This number is provided by Duns and Bradstreet (DUNS) to prove legitamcy of the facility in the country it is located in. This number is now needed for all Domestic/Foreign Food Facility Registrations as of October 31, 2020. We provide DUNS Request Assistance , If you would like more information please Contact Us.
Are nutrition labels required on all foods?
All food products require proper labeling to be admitted into the United States. The U.S FDA is very strict when it comes to labeling and will detain products that do not follow FDA Labeling Guidelines. FDA Registration Assistance can help you get your Food product labels up to the U.S FDA Guidelines. Contact us for more information
What is FSVP?
Foreign Supplier Verification Program (FSVP) was created as a part of the Food Safety Modernization Act (FSMA). It requires food importers to verify through inspections and written protocols that all links in their supply chain are observing FDA food safety practices in the preparation and transportation of food. This process demonstrates to the FDA that importers are also going through the proper steps to ensure that foods are safe to consume. We can help you create a FSVP plan for more information please contact us.
Are U.s agents required?
The United States Food and Drug Administration (FDA) requires all Foreign Food Facilities, Drug Establishemnts and Medical Device Manufacturers to have an official U.S Agent with a physical office in the United States to handle all communications between the FDA and the manufacturer of the goods. If you are in need of a U.S Agent please contact us.
What is a FDA Import Alert?
A FDA Import Alert is a automatic detention for any products coming in under a specific manufacturer due to past infractions with FDA guidelines. The FDA requires all facilites to prove with 5 or more shipments that their products have changed and are following FDA Guidelines to be taken off the Import Alert list. For more information on how we can help you with eliminating your Import Alert please Contact us.
Do I need to register hand sanitizers with the u.s fda?
The short answer is yes. All hand sanitizers are required to be registered with the Food and Drug Administration. The registration ensures that their is a responsible party incase of issues in the formula or label of the Hand Sanitizer. FDA Registration Assistance can help you with this process , For more information please Contact Us.
Do I need to register my otc drug facility?
Yes, to be able to import your product you must register with the FDA. The FDA requires you to renew this registration every year and have a U.S Agent whether you are a domestic or foreign supplier. Here at FDA Registration Assistance we charge $449/ per year for the Drug Establishment Registration. If you would like to get started please Contact Us today.