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As global travel and trade resurge after pandemic restrictions - from cultural phenomena like Sheng Tang Secret Box to Zibo BBQ fever - cross-border commerce faces both opportunities and challenges.
For international traders, navigating complex FDA clearance processes with potential delays, inspections, and seizures can feel like an obstacle course. Our 5-step solution ensures smooth sailing through U.S. customs.
● FDA holds jurisdiction over imported products
● Upon detention:
◆ Immediately request detention notice (FDA Form 2877)
◆ Clarify requirements: "Why detained? What documents needed?"
◆ Submit response within strict deadlines (typically 10-30 days)
● Submit complete, current documentation:
◆ Certificate of Analysis (CoA)
◆ Country of Origin certificates
◆ Product composition details
◆ Quality inspection reports
● Verify all product categories match filings
● Standard 3-5% inspection rate
● If sampled:
◆ Provide full testing cooperation
◆ Prepare appeal evidence for potential hearings
◆ One-time appeal opportunity for non-compliant items
● For quality/technical issues:
◆ Negotiate corrective action plans
◆ Implement FDA-required modifications
◆ Submit revised compliance documentation
● For irreparable violations:
◆ Voluntarily withdraw shipments
◆ Comply with FDA destruction orders
◆ Execute consumer notifications if required
Navigating FDA clearance demands expertise in cost control, timeline management, and regulatory compliance. As your end-to-end solution provider:
✔ 50 Years of U.S. Customs expertise
✔ Top 1% U.S. customs brokerage
✔ Nationwide Coverage: All ports/rail terminals
✔ 300+ owned trucks & chassis fleet
✔ 40M+ cubic feet warehouse network
✔ 2022 Milestone: 10,000+ 40' containers/month
✔ 4,900+ e-commerce clients served
✔ 150+ Amazon seller partners
◆ Full-port customs clearance
◆ 3PL warehousing & distribution
◆ Cross-docking services
◆ Drayage & intermodal solutions
Let Summit Group be your compliance partner - transforming customs challenges into competitive advantages with white-glove service from port to final delivery.
Contact us today for stress-free FDA clearance! [Insert contact information]
Optimized for: FDA compliance, food imports, medical devices, cosmetics, dietary supplements, and consumer products