We help you lift import restrictions and restore supply chain flow by addressing the full scope of FDA concerns—quickly, credibly, and comprehensively.
Phase 1: Immediate Assessment and Regulatory Strategy
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Analyze FDA’s Import Alert, refusal documentation, or detention notice
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Identify the regulatory trigger: inspection findings, sample failures, labeling gaps, etc.
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Assess urgency and business impact
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Develop a resolution strategy aligned with FDA expectations and internal constraints
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Establish communication protocols with FDA, brokers, and customs agents
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Phase 2: Facility Remediation and Quality System Strengthening
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Conduct foreign facility gap assessments (remotely or onsite)
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Correct GMP deficiencies, data integrity concerns, or documentation lapses
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Implement quality system upgrades that align with FDA standards
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Provide training, SOP revisions, and internal audit support
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Coordinate private lab testing if needed for compliance documentation
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Phase 3: Documentation and Advocacy
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Draft and refine response letters, evidence packages, and remediation timelines
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Support FDA meeting prep, including talking points, translations, and follow-up strategy
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Submit required documentation (including third-party test results, CAPAs, and certifications)
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Engage with FDA import compliance reviewers and district offices as needed
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Monitor status and feedback from the FDA during review
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Phase 4: Clearance and Supply Chain Recovery
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Confirm removal from import alert or release of detained shipments
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Help restart shipments with clean documentation and validated controls
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Implement ongoing compliance monitoring systems at the facility level
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Conduct post-release audits or mock inspections to ensure sustained compliance
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Build future readiness to reduce re-alert risk
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