US FDA Drug Establishments Current Registration Site: A Practical Verification Resource

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The US FDA Drug Establishments Current Registration Site is an official public database that allows users to confirm whether drug manufacturing facilities are registered with the U.S. Food and Drug Administration (FDA). This online system supports transparency by displaying establishments that have completed FDA drug establishment registration and remain in active status.

For pharmaceutical manufacturers, importers, distributors, and regulatory professionals, this site is a critical tool for verifying facility compliance before products enter the US market.

What the Registration Site Is Used For

The FDA uses the Drug Establishments Current Registration Site to maintain visibility over facilities involved in manufacturing, processing, packing, or labeling drug products. The database helps the agency:

Identify where drugs are manufactured or handled
Determine which facilities fall under FDA inspection authority
Support import screening and compliance checks
Assist with recalls and safety investigations

For industry users, the site provides a fast and reliable way to confirm whether a facility has an active FDA establishment registration.

What Information Appears in the Database

The registration site typically displays:

Establishment name
Company name
Address and country
Registration status

Both US-based and foreign drug establishments are included, provided they have completed registration and annual renewal.

It is important to understand that appearance in the database does not indicate FDA approval. Registration only confirms that a facility has met administrative notification requirements.

Facilities Required to Appear on the Site

The following types of establishments are required to register with the FDA and appear in the database:

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

All facilities must renew their registration every year to remain active.

How to Search the Current Registration Site

Users can search the database using:

Establishment or company name
Address or country
Registration number

Search results provide basic facility details and registration status, making it easy to confirm whether a site is currently registered.

Because registration status can change after annual renewal, periodic verification is recommended.

Annual Renewal and Data Accuracy

FDA drug establishment registration must be renewed each year between October 1 and December 31. Facilities that fail to renew may appear as inactive or may no longer display in current search results.

Maintaining accurate and up-to-date registration data ensures continued visibility in the database and helps avoid shipment delays or compliance findings.

Common Misunderstandings About the Site

Some frequent misconceptions include:

Thinking database listing equals FDA approval
Assuming registration is permanent
Believing products made at registered facilities 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 Matters

Ensuring that a facility appears correctly on the registration site requires accurate initial registration, timely renewals, and consistent data maintenance. Even small errors can lead to inactive status or regulatory 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 seeking reliable FDA registration assistance can contact support@xproamerica.com for professional guidance.

Conclusion

The US FDA Drug Establishments Current Registration Site is a vital verification resource for confirming registered drug manufacturing facilities. However, remaining correctly listed requires ongoing attention and regulatory accuracy.

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