FDA Establishment Registration
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FDA Establishment Registration

Complete Registration and Listing Compliance

Overview

All establishments that manufacture, prepare, propagate, compound, or process drugs for US distribution must register with FDA and list their products. This includes foreign establishments importing products into the US. Our establishment registration services ensure your FURLS registration is accurate and current, your drug listings are complete, and your annual renewals are submitted on time. We handle the complexity of FDA's registration system so you can focus on your business.

Key Features

Initial FDA establishment registration in FURLS
Drug listing and NDC assignment support
Annual registration renewal management
Registration status monitoring
Labeler code acquisition
Multi-site registration coordination

Our Process

1

Information Gathering

We collect establishment details, product information, and documentation needed for registration.

2

FURLS Registration

We complete your establishment registration and drug listings in FDA's FURLS system.

3

Verification & Confirmation

We verify registration acceptance and provide you with confirmation documentation.

4

Ongoing Maintenance

We monitor renewal deadlines and ensure your registration stays current year over year.

Project Complete & Deliverables Provided

Frequently Asked Questions

FDA establishment registrations must be renewed annually between October 1 and December 31 for the following calendar year. Failure to renew on time can result in your establishment being marked as inactive, which can trigger import holds and other compliance issues. We track these deadlines and handle renewals proactively.

Why Choose Us

  • Accurate and compliant FDA registration
  • Never miss an annual renewal deadline
  • Complete drug listing with proper NDC codes
  • Avoid import holds due to registration issues
  • Expert navigation of FURLS system requirements

Get More Details

Request a personalized consultation and detailed information about this service.

Personalized consultation
Detailed service information
Custom timeline & proposal
Request Information

We'll respond within 24 hours

Ready to get started?

Contact our team to discuss your specific needs for Establishment Registration.

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What Our Clients Say

"We had been struggling with FURLS and weren't sure if our registration was complete. Adelphi audited our registration, corrected several issues, and now manages our annual renewals. It's one less thing we have to worry about."

Marie Dubois

Quality Director

Contract Manufacturer

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