Service overview
We find the root cause of your Import Alert, build the corrective action plan and evidence the FDA expects, and manage your removal petition.
Why this service matters
- Products on Import Alert face detention without physical examination at US ports.
- Detained goods cannot enter unless the importer provides sufficient evidence of compliance.
- Common triggers include contamination, mislabelling, unapproved ingredients and FSVP failures.
Import Alert Investigation & Risk Assessment
We review the Import Alert listing, identify the root cause and develop a corrective and preventive action strategy.
- Verification of Import Alert status and reason for placement
- Review of past FDA detentions, warning letters, and inspection findings
- Customised strategy to address FDA concerns and initiate removal
Import Alerts Removal
Corrective Action Plan (CAP) Development
A well-structured Corrective Action Plan (CAP) is needed to demonstrate compliance and support your request to lift the Import Alert.
- Identification of compliance violations and action steps for resolution
- Development of a formal Corrective Action Plan (CAP) for FDA submission
- Supplier compliance verification and risk management strategies
Third-Party Laboratory Testing & Compliance Audits
The FDA requires proof that your products meet safety standards, so we arrange third-party lab testing and compliance audits to support removal.
- FDA-compliant microbiological, chemical, and toxicology testing
- Supplier facility audits to assess GMP compliance
- Submission of test results and compliance reports to FDA
Petition & Evidence Submission to the FDA
Once corrective actions are in place, we prepare and submit a formal petition to request removal from the Import Alert list.
- Preparation of a formal FDA Import Alert removal request
- Submission of compliance documentation, lab test results, and audit reports
- Tracking and monitoring the status of removal proceedings
Ongoing Monitoring & Compliance Maintenance
Maintaining compliance after removal helps prevent future Import Alerts, and we provide ongoing monitoring and support.
- Regular FDA compliance audits and risk assessments
- Supplier monitoring for continued adherence to US regulations
- Responsive support for potential regulatory issues
Facility Registration Verification & DUNS Correction
We handle the full facility registration process for food, beverage, dietary supplement and cosmetic facilities.
- Preparing and submitting your FDA facility registration
- Ensuring accuracy in facility details to avoid delays or errors
- Managing renewals during the biennial renewal period
Ongoing compliance support
Time-Saving
We manage the investigation, evidence and FDA submissions, so your team can keep the business running.
Regulatory Assurance
Corrective actions target the root cause behind the alert and help prevent repeat listings.
Peace of Mind
A structured removal plan gives you a clear route back to uninterrupted US trade.
What you'll need
Removal requests are evidence-led, so start with your full history.
- Import Alert detailsThe alert and the reason your product was placed on it.
- Past FDA findingsDetentions, warning letters and inspection results.
- Laboratory test resultsIndependent testing to support your request.
- Corrective actions takenWhat has changed to address the violation.