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U.S. FDA compliance

Navigating regulatory compliance can be challenging— yet it needn't be overwhelming.


Our extensive range of services and team of experts specialized in the F&B Industry are ready to assist manufacturers, exporters, and brokers in their regulatory compliance needs to support their export process to the USA.

10+ Years of Experience
U.S. Customs & FDA Support
24/7 Client Support
Holistic Solutions

We aim to provide transparent & efficient 
compliance support


You're probably

  • Why should I pay to register with the FDA?
    Registering with the FDA is free. FDA Regulatory service providers charge an annual fee to cover account management, customer service; while, representing the food facility to all communication requirements with the FDA. It is crucial to appoint as your U.S. Agent an entity located in the USA that excels in FDA Compliance Regulations; while also understands your priorities and can protect your business efforts in the States.
  • I am anxious to comply with the FDA requirements. What should I do to avoid penalties?
    Relax. Relax. Relax. The U.S. FDA will never inspect your facility unannounced; however, FDA will inspect your shipment at the Points of Entry in the USA. In other words, FDA will inspect your shipments at U.S. Customs during clearance. Be prepared before shipping to the U.S. by following the below: ➡️Register wit the FDA ➡️Comply your products' labels ➡️Appoint an FSVP Importer (applies to every shipment)
  • Appointing your U.S. Buyer as your U.S. Agent to the FDA.
    Selling to the USA requires significant time, investment, and effort. While it may seem convenient to pass FDA responsibilities to your buyer with EXW/FOB terms, this can lead to costly mistakes. It is crucial to recognize that FDA regulations are complicated, and your U.S. Agent must possess expertise to navigate them effectively and shield you from demurrage fees. Moreover, appointing your buyer as your U.S. Agent relinquishes control over your facility's FDA Registration, impacting your ability to expand sales in the USA seamlessly.
  • Who should register with the FDA?
    If you manage a facility involved in making, packaging, or storing food for human or animal consumption in the United States, you must register with the FDA, unless exempt. Domestic facility owners/operators must register regardless of interstate commerce. You can authorize someone else to register your facility. Foreign facilities' U.S. agents may register but aren't obligated to do so. Entities and individuals who do not come into physical contact with food for human or animal consumption, are exempt from registering with the FDA.
  • Can you explain the FDA Registration in simple words?
    Most certainly! When registering with the FDA the below information are required: - Legal name of production facility - Legal representation of production facility - Location of production facility - Contact person in case of emergency - Description of product categories in production (briefly)
  • Do I need a Prior Notice?
    Prior Notice is required at every shipment to the USA. The prior notice submission contains detailed information about the consumable goods and enterprises related to the goods and their shipment. The prior notice submission includes information about the following: Items themselves – what is it that is being sent.
  • What is the FCE/SID number?
    When registering a production facility with the FDA, we provide details about the building and the product categories manufactured within it. Certain packaging materials, such as aluminum cans, tetrapaks, pouches, and glass jars, can potentially harbor bacteria during production due to water activity. Quality Assurance (QA) managers conduct thorough tests to ensure bacteria elimination during the production process. In summary, the production line represents the Facility Canning Establishment (FCE), and all SKUs manufactured on that line are considered Specific Identifiers (SIDs). Therefore, the FCE registration serves as a unique identifier for the production line, which produces specific SKUs intended for export to the USA.
  • I just want to send samples. Can i avoid FDA Compliance requirements?
    Absolutely no! Samples are treated in the same with as regular commercial shipments. Shipper must have the below before shipping to the USA: - Valid FDA Registration - Valid DUNs Number - Compliant labels - Verify if FCE Number is needed (depends on product)

Specializing in Food, Beverages & Wine 

Our team is well-versed and specialized in Food, Beverages & Wine products entering the U.S. Market.

FDA Registry offers 360-solutions supporting its client with compliance requirements set by U.S. Buyers, Distributors and Retailers. 

FDA Registry supports companies with all required compliance tasks for the Food, Beverage & Wine Industry including FDA facility registrations, DUNS number acquisition, TTB registrations, Label and Ingredient Review, and FSVP requirements.

Ready to ship?
FDA Registry can help you
with FDA & U.S. Customs
to avoid penalty fees & delays

Are you facing FDA compliance issues?
Don't worry,
We are here to help! 


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