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- As your designated U.S. Agent, FDA Agent Pro will:
- Act as your primary FDA contact for all communications, including inquiries, adverse event reports, and product safety issues.
- Facilitate coordination for any FDA inspections or requests related to your products.
- Promptly confirm our appointment upon receipt of the FDA's US Agent acceptance email.
- Forward all FDA correspondence to you immediately and assist with responses as needed.
- Maintain a physical U.S. presence to ensure timely, compliant interactions and help you avoid registration delays or compliance risks.
We've successfully supported over 1,000 foreign companies with FDA registrations, U.S. Agent designations, and related compliance needs.
Your next step to designate FDA Agent Pro as your U.S. Agent:
In the DRLM interface of the FDA's FURLS system (after logging in at https://www.access.fda.gov), when registering or updating a foreign establishment, there is a dedicated section for entering U.S. Agent information. You can also access/update it via the "View/Update U.S. Agent Information" option on the DRLM main menu. Enter the following FDA Agent Pro details:
After you submit your registration, the FDA will contact us for verification, and we will confirm acceptance of the U.S. Agent designation within 24 hours. We'll then send you a confirmation and an official U.S. Agent Certificate for your records.