Companies importing FDA-regulated products into the United States must ensure that shipments meet all regulatory requirements before they can enter U.S. commerce. One of the most important roles in the import process is the Importer of Record.

The Importer of Record is the entity responsible for ensuring that imported goods comply with U.S. regulations, customs requirements, and applicable FDA rules. Without a properly designated Importer of Record, shipments may be delayed, detained, or refused at the port of entry.

FDA Registration Assistance provides professional Importer of Record services, helping international manufacturers and distributors import FDA-regulated products into the United States while maintaining regulatory compliance.

Trusted by more than 1,000 companies across 135+ countries, FDA Registration Assistance helps businesses successfully bring food, cosmetics, pharmaceutical products, and other regulated goods into the U.S. market.

What Is an Importer of Record?

An Importer of Record is the company or entity responsible for ensuring that imported goods comply with all U.S. import laws and regulatory requirements. This role is essential when shipping products into the United States because customs authorities and regulatory agencies rely on the Importer of Record to verify compliance.

The Importer of Record is responsible for submitting import documentation, coordinating with customs brokers, ensuring regulatory requirements are met, and maintaining compliance records for the imported products.

When products are regulated by the FDA, the Importer of Record must also ensure that the facility registrations, product listings, and importer compliance programs are properly maintained.

FDA Registration Assistance helps companies fulfill the Importer of Record role, ensuring that regulatory obligations are handled correctly so shipments can move through the import process smoothly.

Why Companies Need an Importer of Record

Many foreign manufacturers exporting products to the United States do not have a U.S.-based company capable of acting as the Importer of Record. In these situations, a professional Importer of Record service is required to manage the regulatory and customs responsibilities associated with the shipment.

Without a qualified Importer of Record, shipments may be held by U.S. Customs and Border Protection or flagged by the FDA for compliance review.

FDA Registration Assistance provides Importer of Record services that help international companies establish a compliant import structure while maintaining smooth entry into the U.S. market.

Importer of Record Responsibilities for FDA-Regulated Products

When importing FDA-regulated products, the Importer of Record must ensure that the facility responsible for manufacturing the product is properly registered with the FDA. The importer must also confirm that product labeling and documentation meet regulatory standards.

For food products, the importer must ensure compliance with the Foreign Supplier Verification Program requirements. For pharmaceutical products, the importer must verify that drug establishment registration and product listings are properly maintained. Cosmetic products must comply with MoCRA registration and product listing requirements.

FDA Registration Assistance works with importers to verify these regulatory requirements, helping ensure that imported products meet FDA standards before they enter the United States.

Importer of Record Services for International Companies

Foreign manufacturers often require an Importer of Record partner to distribute products within the United States. This is particularly common for companies entering the U.S. market for the first time or companies selling products through distributors or e-commerce platforms.

FDA Registration Assistance supports international companies by providing professional Importer of Record services and guiding them through the regulatory requirements associated with importing products into the United States.

Our team works closely with manufacturers, distributors, and customs brokers to ensure that import documentation and regulatory records are properly handled.

Why Companies Choose FDA Registration Assistance

Companies worldwide rely on FDA Registration Assistance because our team provides reliable regulatory support, accurate documentation, and responsive communication throughout the import process.

FDA Registration Assistance has helped more than 1,000 companies across 135+ countries navigate FDA compliance requirements and successfully bring their products into the U.S. market.

By working with FDA Registration Assistance as their Importer of Record service provider, companies gain a regulatory partner dedicated to protecting their access to the United States marketplace.

Start Your Importer of Record Service Today

If your company needs an Importer of Record to bring FDA-regulated products into the United States, working with an experienced regulatory partner can simplify the process and reduce compliance risks.

FDA Registration Assistance provides professional Importer of Record services, helping international companies import products into the United States while maintaining regulatory compliance.

Contact FDA Registration Assistance today to begin your Importer of Record service and ensure your products enter the U.S. market without regulatory complications.

Frequently Asked Questions – Importer of Record Services

1. What is an Importer of Record?

An Importer of Record is the entity responsible for ensuring that imported goods comply with U.S. import laws and regulatory requirements.

2. Who can act as an Importer of Record?

The Importer of Record must be a U.S.-based entity capable of handling regulatory and customs responsibilities.

3. Do foreign manufacturers need an Importer of Record?

Yes. Foreign manufacturers exporting products to the United States must designate an Importer of Record.

4. What responsibilities does an Importer of Record have?

The importer is responsible for ensuring that imported goods comply with U.S. regulations and that all required documentation is submitted.

5. Can FDA Registration Assistance act as an Importer of Record?

Yes. FDA Registration Assistance provides professional Importer of Record services for companies importing FDA-regulated products.

6. Do food imports require an Importer of Record?

Yes. Food shipments entering the United States must have an Importer of Record.

7. Does the Importer of Record handle FDA compliance?

The importer must ensure that FDA regulatory requirements are satisfied before products enter U.S. commerce.

8. Can a customs broker act as an Importer of Record?

Customs brokers typically manage entry filings but may not assume full importer responsibilities.

9. Do cosmetic imports require an Importer of Record?

Yes. Cosmetic products imported into the United States must comply with U.S. import requirements.

10. Why choose FDA Registration Assistance for Importer of Record services?

Because FDA Registration Assistance provides professional regulatory support trusted by more than 1,000 companies in 135+ countries.