US FDA Certification

US FDA Certification Overview

The United States Food and Drug Administration (US FDA), a federal agency under the Department of Health and Human Services, holds a pivotal role in safeguarding public health. It is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

Certain products require US FDA registration for both domestic and foreign establishments involved in manufacturing, repackaging, or relabeling. Our all-encompassing US FDA registration services cover various categories:

» Food Facility Registration
» Supplement Facility Registration
» Food Canning Establishment Registration
» Foreign Supplier Verification Program
» Medical Device Establishment Registration
» Drug Establishment Registration
» Cosmetic Establishment Registration
» U.S. Agent Service
» Prior Notice
» Label Review

It is important to note that US FDA Establishment registrations follow the FDA's fiscal year, which spans from October 1 to September 30.

DUNS Number Requirement

An essential part of the registration process is acquiring a DUNS Number. This distinctive identifier is mandatory for new registrations or renewals. While the DUNS number is provided at no cost, the application process may take over 30 days. It is recommended to initiate the DUNS number application promptly. Note: Obtaining the DUNS number is the responsibility of the company, and it is not within our scope of work. When contacting us, please ensure you have your company’s DUNS NUMBER available.