We guide exporters and manufacturers with FDA Facility Registration (FFR), U.S. Agent, label review, Prior Notice, and more—so you can enter the U.S. market with confidence.
Miami, FL · ES/EN · Private Company Compliance Service. Not affiliated with the U.S. FDA.
Products sold in the U.S. must meet labeling requirements, including nutrition facts and mandatory statements.
Cosmetics facilities and products must be listed under the MoCRA framework.
Fruits, vegetables, meat, seafood, and dairy may fall under USDA requirements.
The FDA (U.S. Food and Drug Administration) is the government agency that helps protect public health by regulating foods, drugs, biological products, medical devices, and other health-related products. The FDA sets standards and requirements to help ensure product safety, quality, and proper labeling in the U.S.
FDA registration is the process of providing business and facility details required by the FDA. For many categories—especially food facilities—registration supports compliance and is often required before shipping to the U.S.
Companies involved in manufacturing, processing, packing, labeling, holding, importing, or exporting regulated products may need FDA-related registrations or compliance steps. Requirements depend on product category and role in the supply chain.
Depending on the product, requirements may include facility registration, proper labeling, Prior Notice (for food shipments), and additional compliance steps. The exact checklist varies by category and supply-chain role.
Yes—foreign facilities that manufacture, process, pack, or hold certain regulated products for the U.S. market may be required to complete FDA-related registrations and designate a U.S. Agent, depending on the category.
Two common requirements are obtaining a DUNS number (when applicable) and designating a U.S. Agent. We can help you confirm what applies and complete the process.
The FDA generally does not issue “FDA registration certificates.” After completing your registration, you can keep confirmation records. Our team can also provide a service confirmation document for your internal files.
“The Registro-FDA.US team was professional and provided the support we needed to meet FDA requirements. I’m very satisfied with the service and I highly recommend them.”
“I’ve had the opportunity to work with them several times. I’m impressed by their experience and knowledge. I’m very happy with their service and will continue delegating our FDA-related processes to them.”
“The documentation prepared by the Registro-FDA.US team was complete and accurate. I was impressed by how quickly they worked to help ensure our products met FDA requirements.”
To sell products in the United States, you may need to follow FDA, USDA, or TTB requirements depending on your product category. This guide helps you understand the key steps, required information, and common compliance mistakes to avoid.
