FDA Registration
simplified
The U.S. Food and Drug Administration (FDA) plays a vital role in safeguarding public health through the oversight of imported goods.
It mandates that any entity intending to market food, animal, medical, or cosmetic items within the United States must undergo registration with the FDA.
WHO REGISTERS
Facilities & individuals involved in the mentioned food supply chain action, FDA registration is mandatory:
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Facility Owner
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Legal Operator
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Agent in charge engaged in:
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Manufacturing/Processing
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Packing/Re-packing
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Storing/Holding of food for human or animal consumption in the United States
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Facility registration with the FDA is crucial for ensuring consumer safety and maintaining FDA compliance for your company. This process entails providing comprehensive details about your products, manufacturing facilities, quality control measures, labeling, recall procedures, and other relevant information.
While FDA compliance may appear daunting and intricate, it doesn't have to be. Over 4,500 companies in the food, beverage, dietary supplement, and wine industries rely on FDA Registry to simplify the process of FDA registration and ensure regulatory compliance effortlessly.
SERVICES
Specialized in
Food, Beverage & Wine
FDA Regulatory Compliance
Establishments processing or storing Food & Beverages for consumption in the U.S. must register, and renew biennially between October 1st & December 31st, with the FDA before export to the USA. Bioterrorism Act of 2002 and FSMA Regulations aim to safeguard against food supply threats.
The registration process with the U.S. Food and Drug Administration (FDA) mandates that companies outside the United States involved in food and beverage, cosmetic, medical device, drug, and radiation-emitting device industries appoint a U.S. Agent for communication with the FDA.
Our team of experts specializing in FDA labeling, product, and ingredient compliance supports numerous companies across various sectors focusing on food and beverage, dietary supplements, and wine. We assist these businesses in ensuring their products align with FDA regulations.
Our team of professionals provides support for FDA-compliant nutrition facts panels, customized serving sizes, and liquid measurements. Trusted by a wide range of clients, from established industry leaders to up-and-coming food producers, we assist with allergen declarations, QUID ingredient declarations, nutritional tables, and more.
The US FDA rigorously inspects all imports for food safety. Choosing a competent FSVP Importer is vital for smooth customs clearance. They bear responsibility for product safety upon entry to the US market. Avoid delays with our expert FSVP solutions led by seasoned regulatory professionals.
FDA REGISTRATION
Registering Your Facility
DUNS & UFI
In 2016, the FDA mandated that drug and food facilities include Unique Facility Identifiers (UFIs) in their FDA registration and renewal processes. Currently, the FDA only accepts Data Universal Numbering System (DUNS) numbers as UFIs, which are unique identifiers created by Dun & Bradstreet (D&B) for business profiling purposes.
For FDA registration, all food facilities are required to incorporate their DUNS number. Failure to provide an accurate DUNS number may lead to the cancellation of registration.
FDA REGISTRY Service:
Every entity receives to receive support in the below mentioned services after completing FDA Registration with FDA Registry:
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FDA registration and renewal assistance
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DUNS number assistance
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24/7 U.S. Agent representation
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Prior Notice filing Support
Is your facility involved in the manufacturing, processing, packaging, or storage of food or beverages intended for consumption in the United States? Since the enactment of the Bioterrorism Act of 2002 and the Food Safety Modernization Act (FSMA) of 2011, the FDA mandates that all food and beverage companies register and periodically renew their registrations. This requirement aims to mitigate the risks of food-related attacks, hazards, threats, and emergencies.
Food and beverage establishments are obligated to register with the FDA prior to exporting to the U.S. Furthermore, they must renew their registrations every two years during the designated period between October 1st and December 31st
FDA Registration Certificate
After a company completes registration, the U.S. FDA assigns registration numbers without issuing Certificates of Registration. However, numerous buyers or importers may still demand confirmation of registration from their suppliers.
If your facility is already registered with the FDA, FDA Registry can furnish a third-party Certificate of Registration, validating your FDA registration status for buyers, customs brokers, and suppliers. Our services are focused mainly to companies in the food, beverage and wine sectors.
If your facility remains unregistered with the FDA, collaborating with FDA Registry can facilitate the registration process and procure a third-party Certificate of Registration."
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FDA registration numbers may unexpectedly become invalid, leading to delays or detentions at entry ports. Common reasons for invalidation include:
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Outdated ownership details,
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Registration not being submitted by an authorized individual,
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Refusal by the facility's U.S. Agent to accept the designation,
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Failure to renew registration before the deadline.
At FDA Registry, we offer complimentary verification of U.S. FDA registrations. Through our service, you can promptly verify the validity of your facility's registration and take necessary corrective measures to avoid potential fees or penalties.