FSVP Regulatory Compliance Technical Advisory Services
Informed Guidance for Confident U.S. Market Entry Decisions
This service provides structured, on-demand technical advisory support for clients seeking clarity on FSVP compliance-related matters. It is suited for inquiries that require research, assessment, and professional interpretation of regulatory expectations. Clients receive guidance that can be used internally for decision-making or for planning next steps in their compliance activities.
This package provides access to a FSVP Qualified Individual (QI) for advisory, clarification, and compliance direction.
Scope of Work
Regulatory Guidance & Interpretation
• Clarification of FDA Foreign Supplier Verification Program (FSVP) regulatory requirements under 21 CFR 1 Subpart L
• Interpretation of FDA guidance documents, warning letters, and current inspection and enforcement trends
• Advisory support on importer responsibilities, U.S. agent roles, and FSVP importer designation
• High-level gap assessment against FDA FSVP compliance and documentation expectations
FSVP Program Advisory
• Guidance on FSVP implementation, including:
◦ Hazard analysis expectations
◦ Supplier approval and qualification criteria
◦ Verification activities (COAs, audits, and testing)
◦ Corrective action expectations
• Advisory support for existing FSVP programs
• Review of client questions and documentation prior to FDA interactions (non-representation)
Supplier and Product Advisory
• Advisory on foreign supplier documentation
• Guidance on product-specific FSVP risks
• Recommendations for supplier verification frequency
• Import readiness advisory (pre-shipment guidance only)
Note: Exclusions (billed as separate service/s)
• FSVP file creation or drafting
• Supplier hazard analysis development or implementation
• FDA inspection representation
• U.S. Agent services
• Shipment approvals or importer sign-off
• Corrective action execution
• Label compliance reviews
• Internal audits and gap assessments
Deliverables
• Documented technical advisory (e.g., via documented response, call, or email correspondence) outlining:
◦ Applicable FSVP regulations and reference basis
◦ Assessment and interpretation of the client’s inquiry
◦ Key considerations and recommended next steps
• Email support for clarification questions related to the advisory issued
Pricing Structure
• Flat Rate: $350 — Covers up to 10 hours of technical advisory work (regulatory review + advisory), availed either one-time or on a monthly basis
• Additional Hours: $29 per hour (applicable only if scope exceeds the initial 10 hours; pre-approved by client)
• Note: Hours do not roll over to the next billing cycle
Ideal For:
• Businesses seeking clarity on U.S. import and FDA FSVP requirements
• Importers and/or distributors exploring compliance implications prior to importation
• Manufacturers preparing for regulatory verification
• Organizations that require expert technical interpretation without engaging in full compliance services
• Clients who submit frequent regulatory questions and prefer a packaged advisory format
If you require professional guidance on U.S. importing matters, FSVPServices.com is prepared to assist. Kindly reach out to initiate your advisory engagement or to request an engagement schedule.
Fees and Subscriptions
| Package | Setup Fee | Monthly Maintenance | Notes |
|---|---|---|---|
| Amazon Basic Setup | $650 | N/A | Amazon Store Setup only |
| Amazon Standard | N/A | Starts at $750/month | End-to-end Store Management |
| Amazon FSVP Package | N/A | Custom Quote | FSVP Setup + Amazon Setup + Ongoing Store and Compliance Management |
Optional Add-Ons:
• FDA Facility Registration: Starts at $550/facility
• FSVP Agent Services: starts at $749/year
• Label Compliance Review: $750/SKU
Key Benefits
✔ Amazon FSVP compliance documentation handled
✔ Reduce Amazon account suspensions or listing removals
✔ Full FDA compliance support integrated
✔ Peace of mind with expert guidance
✔ Ongoing maintenance to keep Amazon & FDA records up-to-date
