For pharmaceutical, food (including food products, health supplements, feed, etc.), and cosmetic manufacturers, we provide:

1.U.S. Agent Services

2.Registration Applications: Facility registration and product listing

3.DUNS Number Application Assistance

4.Annual Maintenance Services

5.Special Projects: Small business qualification applications, compliance guidance, etc.

For customized solutions, please contact us for professional support.

1. Definition and Background

U.S. FDA Establishment Registration and Product Listing are mandatory procedures for market entry. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), all facilities involved in manufacturing, processing, packing, or storing FDA-regulated products (food, drugs, cosmetics, etc.) must register with FDA and list their products in FDA databases.

·Establishment Registration: Submission of facility information to obtain unique identifiers (e.g., FEI number).

·Product Listing: Submission of product details (ingredients, intended use, classification) to generate Listing Numbers.

FDA uses this system to ensure product safety and traceability, with frequent regulatory updates.

2. Applicable Scope

·Drugs: All prescription drugs, OTC products, biologics, and vaccine manufacturers.

·Food: Processors, packers, and storage facilities (biennial renewal required).

·Cosmetics: Mandatory facility registration and product listing per MoCRA (2023), with small business exemptions.

3. Basic Requirements

·Business Credentials: Legal entity documentation and facility address proof.

·U.S. Agent: Foreign firms must designate a U.S. Agent for FDA communications.

·Technical Files: FDA-compliant product formulations, test reports, and labeling.

4. Registration Process

1）Pre-Submission:

Obtain DUNS Number.

Create FDA payment account (linked to DUNS).

2）Submission: Product-specific data per category.

3）Annual Maintenance.

5. Regulatory Basis

·Drugs: 21 CFR Part 207 (Registration and Listing).

·Food: 21 CFR Part 1.227 (FSMA).

·Cosmetics: MoCRA (2023, mandatory registration/listing).