Received an Import Alert?
We Can Help.
Import Alerts can halt shipments and trigger costly delays. If listed, your products may face automatic detention (DWPE). To resume trade, you must prove compliance through corrective actions and repeated clean shipments. Registrar Corp guides you through the removal process with expert, FDA-ready petitions..
2,000+ Medical Device Manufacturers Trust Registrar Corp
What is Detention Without Physical Examination (DWPE)?
When FDA places a company or product on Import Alert, future shipments are automatically detained at the border without inspection.
Why It Happens:
- Regulatory violations (labeling, quality, safety)
- Repeated failed FDA inspections
- Adulteration or misbranding
- Public health concerns
What It Means:
- Shipments blocked at entry
- Requires corrective action and FDA petition for removal
Expert Support Helps Avoid:
- Costly setbacks
- Product expiry
- Product damages due to detainment
How to Petition FDA for Removal from an Import Alert
To be removed from an Import Alert, FDA requires:
- Corrective Action EvidenceProof that you have addressed the compliance issue(s)
- Multiple Compliant ShipmentsSuccessfully imported shipments that meet FDA regulations
- Formal Written PetitionA detailed submission outlining your corrective measures
How Registrar Corp Helps You Resolve an Import Alert
Resolving an import alert can be complex. Registrar Corp simplifies this process by:
Compliance Assessment
We analyze the reasons for your Import Alert and assess the necessary corrective actions.
Corrective Action Plan Development
Our regulatory specialists work with you to fix compliance issues, update documentation, and ensure your medical devices meet FDA requirements.
Evidence Compilation & Submission
We gather the required proof, assist in submitting multiple compliant shipments, and prepare your formal petition.
Direct FDA Liaison
We communicate directly with FDA on your behalf to facilitate a quicker review and approval process.
With Registrar Corp’s 20+ years of regulatory experience, we help businesses efficiently navigate Import Alerts, minimize disruptions, and regain market access faster.
Case Study: Successfully Removing a Medical
Device Manufacturer from Import Alert
Challenge:
A European manufacturer of Class I & II orthopedic implants was placed on FDA’s Import Alert Red List due to quality system deficiencies. US distributors halted orders, detained shipments piled up at ports, and revenue losses escalated.
Solution:
Registrar Corp conducted a full regulatory audit, corrected compliance gaps, facilitated multiple compliant shipments, and submitted a removal petition to FDA.
Results:
Import Alert removed in under 90 days, enabling the company to resume US sales swiftly.
Why Choose Registrar Corp for Import Alert Removal?
20+ Years of FDA
Regulatory Expertise
Trusted by thousands
of global manufacturers
Faster Import Alert
Resolution to Minimize
supply chain disruptions
and lost revenue
Comprehensive
Compliance Support
From risk assessment
to petition drafting
Direct FDA Liaison
We handle communication
with FDA for a
smoother process
We Will Help You Regain Market Access
and Restore Your Supply Chain
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