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FDA Import Alert Green List Petition Service
When a company is placed on an FDA Import Alert (such as Import Alert 99-21 for food products or 16-120 for drug products), its shipments may be automatically detained at the U.S. border without physical examination. This can severely impact your business operations and damage your reputation with U.S. buyers. To resume normal import activities, foreign firms must submit a formal petition to be added to the FDA’s Green List, demonstrating their full compliance with U.S. regulations. At J&B Food Consulting, we specialize in preparing and submitting successful Import Alert Removal Petitions, helping clients restore market access quickly and effectively.
Why You Need This Service
Release from Detention Without Physical Examination (DWPE)
Only companies on the Green List are allowed to ship without automatic detentions.
Demonstrate Corrective Action
The FDA requires documented proof that you have identified and corrected the issues that led to the alert.
Resume Normal Trade with the U.S.
Being removed from Import Alert allows you to regain access to U.S. distribution and retail partners.
Avoid Costly Delays
Without proper guidance, petitions may be rejected or significantly delayed.
Our Services Include
Root Cause Analysis Support
We help you investigate and document the root cause of the violation (such as mislabeling, contamination, or banned substances).
Petition Documentation and Submission
We prepare and submit the full petition package, including supporting evidence, CAPs, lab results, and firm profile documentation.
Corrective Action Plan (CAP) Development
We assist in creating detailed and FDA-acceptable CAPs with proper timelines, implementation records, and process improvements.
Communication with FDA Compliance Officers
We act as your liaison, ensuring clear and timely communication with the FDA district office throughout the review process.
Who Needs This
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Foreign manufacturers, processors, or shippers subject to FDA Import Alert
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Exporters with repeated FDA violations or refusals
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Private label or contract manufacturers impacted by DWPE
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Companies seeking faster re-entry to the U.S. market
Why choose us?
Proven Petition Success: Extensive experience submitting Green List petitions for food, dietary supplements, and cosmetics
Precise and Reliable Analysis: Over 15 years of experience in U.S. FDA import compliance and enforcement response
Detailed and Compliant Documentation: We ensure every petition meets FDA expectations and documentation standards
Multilingual Support: Korean, English, and more for seamless communication and understanding
Full Transparency and Support: We guide you step-by-step until you’re officially listed on the FDA Green List