FDA Import Alert Recovery Services | DWPE Shipment Coordination & Documentation Support
Based on FDA Import Alert, Detention Without Physical Examination (DWPE), and related FDA import admissibility requirements
This service assists importers, manufacturers, and foreign suppliers with shipment coordination and supporting documentation management for products subject to FDA Import Alert or Detention Without Physical Examination (DWPE). The service includes shipment documentation coordination, supporting evidence organization, product testing and release documentation review support, and recovery evidence management intended to support future FDA Import Alert recovery efforts.
All services are administrative and facilitative in nature and are performed using information provided by the client, supplier, manufacturer, or customs broker. Services do not transfer regulatory responsibility and do not constitute legal representation, FDA petition preparation, corrective action implementation, or regulatory approval. FDA admissibility and Import Alert removal decisions remain solely under FDA authority.
Scope of Work
Import Alert Recovery Program Setup
- • Review of Import Alert reference and affected product information
- • Coordination of supplier, importer, and shipment details
- • Organization of available shipment history and FDA correspondence
- • Shipment checklist, tracking log, and evidence repository setup
- • Recovery document organization and indexing
Shipment Documentation Coordination
- • Review of shipment documents for completeness and consistency
- • Coordination of invoices, packing lists, Bills of Lading, and shipment records
- • Shipment tracking and evidence organization
- • Follow-up on missing shipment documentation
Product Testing & Supporting Records
- • Organization of product specifications and Certificates of Analysis (COAs)
- • Coordination of product release and testing records
- • Review of shipment-related supporting documents
- • Identification of missing records or documentation gaps
Customs Broker & FDA Coordination Support
- • Shipment coordination with customs broker and designated contacts
- • Organization of shipment-related FDA communications
- • Coordination of requested shipment documentation
- • Shipment activity and status tracking
Recovery Evidence Management
- • Shipment chronology and release history organization
- • Supporting evidence tracking and indexing
- • Recovery documentation organization
- • Final recovery records preparation
Deliverables
- • Shipment tracking log
- • Shipment documentation package(s)
- • Product testing and supporting record repository
- • Recovery evidence package
- • Evidence gap tracker
- • FDA shipment communication records
- • Final recovery documentation package
Fees and Subscriptions
Recovery Support Packages
| Package | Fee (USD) | Action |
|---|---|---|
| FDA Import Alert Recovery Coordination & Remediation Support Services – Per Shipment Engagement | $3,600.00 (per shipment / one-time) | Purchase |
| FDA Import Alert Recovery Coordination & Remediation Support Services – Full Program Engagement (Up to Five Shipments) | $15,000.00 (project-based) | Purchase |
Ideal For
- • Importers with products subject to FDA Import Alert or DWPE
- • Foreign suppliers or manufacturers supporting recovery shipments
- • Businesses organizing shipment and testing records for FDA review
- • Companies seeking structured shipment recovery coordination
Important Notes
- • Commercially released shipments alone may not guarantee Import Alert removal
- • FDA may require additional records, testing, corrective actions, or supporting evidence
- • Clients remain responsible for product compliance and regulatory obligations
- • Services are limited to administrative coordination and document support
- • FDA admissibility and Import Alert removal decisions are determined by authorities
