Stuck on an FDA Import Alert?
Let’s Get You Off the List.

TFacing an FDA Import Alert can halt your shipments and drain your revenue. When your drug product is flagged, Detention Without Physical Examination (DWPE) results in automatic holds at U.S. ports, leaving no way forward without immediate corrective action.

Registrar Corp helps pharmaceutical companies navigate FDA challenges with precision. Our experts prepare compliant petitions, guide corrective actions, and accelerate product re-entry into the U.S. market.

Resolve Import Alert

3,000+ Drug Manufacturers Trust Registrar Corp

What is an FDA Import Alert or DWPE?

FDA issues Import Alerts to stop products suspected of violating US. regulations from entering the country. When under DWPE, your shipments may be detained without inspection often due to past violations, labeling issues, or facility concerns.

Common Causes include:

Misbranding or improper labeling
Presence of unapproved drugs or ingredients
Recurring product non-compliance
Lack of prior approval or registration
cGM P (Good Manufacturing Practice) violations

If you’re on an FDA Import Alert, your shipments won’t move without proving compliance.

How Registrar Corp Helps

We guide you through every step of addressing and resolving import detentions:

Root Cause Review

We help you understand the FDA’s reasoning Notices of Action (NOAs) so you can identify potential root causes and begin resolving the issue with clarity. While you’ll lead the internal investigation, we ensure you start in the right direction.

Corrective Action Planning

We work with you to build and implement a compliance strategy that addresses FDA concerns and helps move you toward removal from Import Alert.

Documentation Submission

We handle the preparation and submission of required documents to support the release of your detained goods. If your products meet FDA standards, we’ll submit a Test of Acceptability (TOA) on your behalf. If reconditioning is needed, we’ll guide you on next steps offered as a separate service.

Strategic Communication

We communicate directly with the FDA for you saving you time, reducing errors, and ensuring your responses are timely and compliant.

Monitoring & Prevention

We help you stay ahead with ongoing alerts, renewal reminders, and proactive audit support so you can avoid future detentions and stay in control of compliance.

Why Choose Registrar Corp?

24/7 support for urgent
detention or refusal
cases

Over 30,000 clients
served in 160+
countries

Regulatory experts with
FDA communication
experience

End-to-end service
from root cause
to reinstatement