US FDA Drug Establishments Current Registration Site: Facility Verification Guide

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The US FDA Drug Establishments Current Registration Site is an official online resource used to verify drug manufacturing facilities registered with the U.S. Food and Drug Administration (FDA). This database supports regulatory transparency by allowing stakeholders to confirm whether a pharmaceutical establishment holds an active FDA drug establishment registration.

For manufacturers, importers, distributors, and compliance professionals, this site is a critical tool for due diligence and regulatory verification.

Understanding the FDA Drug Establishments Current Registration Site

The FDA Drug Establishments Current Registration Site contains records of domestic and foreign facilities that have submitted FDA drug establishment registration. These records typically display:

Establishment name
Company name
Address and country
Registration status

The database is updated regularly and reflects establishments that have completed registration and annual renewal requirements.

It is important to understand that being listed does not mean FDA approval. Registration only confirms that the establishment has met administrative notification obligations.

Why the FDA Maintains This Database

The FDA uses the current registration site to maintain oversight of drug manufacturing infrastructure supplying the United States market. The database helps the FDA to:

Identify where drugs are manufactured or processed
Determine facilities subject to FDA inspection
Support import screening and compliance checks
Assist with recalls and safety investigations

For industry users, the database provides a reliable method to verify facility registration before entering business relationships.

Who Appears in the Database?

The registration site includes establishments such as:

Prescription drug manufacturers
Over-the-counter (OTC) drug manufacturers
Contract manufacturing organizations (CMOs)
Repackers and relabelers
Foreign drug manufacturers exporting to the US

All these facilities must register annually to maintain active status.

How to Search the Registration Site

Users can search the FDA Drug Establishments Current Registration Site using:

Establishment or company name
Address or country
Registration number

Search results show basic facility details and whether the establishment is currently registered.

Because registration status can change, periodic verification is recommended.

Annual Registration and Database Updates

FDA drug establishment registration must be renewed every year between October 1 and December 31. Facilities that fail to renew on time may appear as inactive or may not display in current search results.

This makes annual renewal critical for maintaining visibility in the database and avoiding compliance issues.

Common Misconceptions

Some frequent misunderstandings include:

Assuming registration equals FDA approval
Believing registration is permanent
Thinking products listed under a facility are automatically FDA-approved

In reality, registration is a recurring administrative requirement and does not evaluate product quality, safety, or effectiveness.

Why Professional FDA Registration Support Is Important

Ensuring that your facility appears correctly on the FDA registration site requires accurate initial registration, timely renewals, and proper data maintenance. Errors or missed deadlines can result in inactive status or shipment delays.

XPRO America, a US FDA Consultancy, provides comprehensive FDA drug establishment registration services, including new registrations, annual renewals, data verification, and US Agent support for foreign companies.

Organizations needing reliable assistance with FDA registration and database compliance can contact support@xproamerica.com for professional guidance.

Conclusion

The US FDA Drug Establishments Current Registration Site is a vital tool for verifying registered drug manufacturing facilities. However, maintaining correct and active registration requires continuous attention.

By ensuring proper FDA establishment registration—and partnering with an experienced US FDA Consultancy—companies can reduce compliance risk, avoid supply chain disruptions, and maintain uninterrupted access to the US pharmaceutical market.