U.S. Agent / FSVP Agent / FSVP-QI Compliance Monthly Service
Comprehensive FDA Import Compliance Support — Simplified, Scalable, and Affordable
Ensure your business stays compliant with the Foreign Supplier Verification Program (FSVP) under 21 CFR 1.500–1.514 through our structured Monthly Subscription Service.
Whether you’re a brand owner, importer, or distributor, our team of Qualified Individuals (FSVP-QIs) and U.S. Agents provides complete, hands-on compliance management that adapts to your business size and operational complexity.
Transparent Monthly Pricing
Pay-As-You-Go Compliance Support
Only $12/hour for dedicated support from an FSVP Qualified Individual (FSVPQI)
- Use your time for:
- • Urgent FSVP guidance during customs issues
- • Program developments or updates
- • Foreign supplier documentation reviews
- • Pre-audit preparation and FDA inspection readiness
- • Import compliance risk assessments
- • Label and document reviews
Audit-Ready Compliance Reviews
Ensure your FSVP documentation meets FDA standards under 21 CFR 1.500–1.514.
- Available on-demand:
- • Verification of supplier documentation
- • Review and/or updating of SOPs
- • Records organization for FDA audit readiness
Why Choose On-Demand Support?
• Pay-as-you-go or recurring monthly blocks
• U.S. and international support
• Qualified, experienced, and documentation-ready
• Access qualified FSVP experts without hiring full-time staff
• Build compliance confidence while managing your budget
• NDA and client confidentiality guaranteed
Transparent Monthly Pricing
Our tiered monthly structure is designed for flexibility and scalability — allowing you to build your compliance program around your exact needs. Each coverage type focuses on a specific layer of FSVP responsibility: the enterprise system, supplier oversight, and product-level verification.
| Coverage Type | Description | Monthly Rate | Annual Rate |
|---|---|---|---|
| US Agent, FSVP Agent, FSVPQI, Enterprise / System Compliance Coverage |
At the enterprise level, we serve as your official U.S. Agent and FSVP program manager, handling all FDA communications, registration updates, and program oversight. This includes setup, maintenance, and coordination of your FSVP system to ensure alignment with FDA 21 CFR 1.500–1.514 requirements. Key Inclusions: • U.S. Agent designation and FDA communication handling • FSVP system setup and master file organization • Compliance calendar management and FDA registration monitoring • Oversight of supplier and product-level compliance activities • Quarterly compliance summary and management reporting FSVP Management System: • FSVP/Supplier Management Module – monitor supplier compliance • Customer Management Module – track importer and customer information • Imported Product Management Module – manage each product’s details, documentation, and variations • Importer of Records Management Tool – maintain import records and traceability Note: Limited to 1 user per system; Additional user - $65.00 per month or $702.00 per year |
$75.00 | $810.00 |
| Supplier Compliance Coverage (per Supplier) |
Provides continuous monitoring and verification of each foreign supplier’s documentation to ensure FSVP compliance. Includes evaluation of supplier risks, corrective actions, and annual verification updates. Key Inclusions: • Supplier approval and documentation tracking • Hazard analysis and risk-based evaluation verification • Review of supplier audit reports and corrective actions • Annual supplier re-verification and performance updates • Communication support between importer and supplier Scope of Service – Facility Compliance Regulatory Basis for Review Frequency: • Monthly Review: High-risk or frequently updated documents • Quarterly Verification: Moderate-risk documents periodically validated • Annual Review: Long-term certifications and audits verified for currency I. Monthly Review and Update – Facility (High-Risk): Allergen Declarations, FSMA Compliance Statements, Pest Control, Product Safety Policies, Recall Program, Sanitary Programs, Product List/Register, FFVA/VACCP, Traceability Systems. II. Quarterly Verification – Facility (Moderate-Risk): Certificates of Insurance, Contracts/Agreements, Hazard Analysis Forms, Water Tests, cGMP Certificates, Supplier Questionnaires. III. Annual Review – Facility (Long-Term): Third-Party Audit Certificates & Reports, Organic Certificates, Mock Recall, FDA Bioterrorism Registration. IV. FSVP Monthly Maintenance – Facility: Emergency Contact List, FSVP Forms & Checklists, Importer Agreements, Product Registers, U.S. Agent Info |
$50.00 | $540.00 |
| Product / Material Variation Compliance Coverage (per SKU) |
Ensures every product or variation imported meets FDA safety and documentation requirements. We handle recordkeeping, verification, and inspection readiness at the product level. Key Inclusions: • Product-specific FSVP documentation management • Label compliance and specification review (basic check) • Verification of testing reports, COAs, and certifications • Maintenance of product-specific verification records • Import entry cross-checks and traceability support Material Compliance (Moved from Supplier Coverage) Regulatory Basis for Review Frequency: • Monthly Review: High-risk or frequently updated material documents • Quarterly Verification: Moderate-risk material documents • Annual Review: Long-term product-related certifications I. Monthly Review – Material (High-Risk): COAs, Certificates of Conformity, HACCP Plans, Product Labels, Product Specifications, SDS, Shelf-Life, Authenticity, Transportation Agreements, Certification Claims (BPA-Free, Gluten-Free, Halal, Kosher, Organic, Vegan). II. Quarterly Verification – Material (Moderate-Risk): Authenticity Validation, Chemical Migration Testing, Label Verification, Packaging Compliance. III. Annual Review – Material (Long-Term): Organic, Halal, Kosher, Non-GMO, Vegan Certificates. IV. FSVP Monthly Maintenance – Material: Bill of Lading, CBP Filing Forms, Country of Origin Certificates, Import Certificates, Product Description Forms. Note: Additional SKUs are $15 per SKU per month. |
$25.00 | $270.00 ($162.00 per additional SKU) |
Note: An annual subscription is available at a 10% discount compared to the standard monthly plan.
What’s Included
✔ Official U.S. Agent and FSVP-QI representation under FDA regulations
✔ End-to-end documentation and verification management
✔ FDA inspection readiness and records organization
✔ Supplier and product performance monitoring
✔ SOP review and maintenance of verification activities
✔ Compliance reporting and program updates
✔ Secure and confidential data management under NDA
✔ End-to-end documentation and verification management
✔ FDA inspection readiness and records organization
✔ Supplier and product performance monitoring
✔ SOP review and maintenance of verification activities
✔ Compliance reporting and program updates
✔ Secure and confidential data management under NDA
Why Choose Our Monthly Service
• Predictable, flat-rate monthly pricing — no hidden costs or hourly billing
• Scalable design — pay only for the number of systems, suppliers, and products you manage
• Access to certified FSVP Qualified Individuals and experienced U.S. Agents
• Ensures continuous compliance without maintaining internal staff
• Supports both U.S. and international operations
• Audit-ready documentation and transparent reporting for complete confidence
• Scalable design — pay only for the number of systems, suppliers, and products you manage
• Access to certified FSVP Qualified Individuals and experienced U.S. Agents
• Ensures continuous compliance without maintaining internal staff
• Supports both U.S. and international operations
• Audit-ready documentation and transparent reporting for complete confidence
Ideal For
• Importers requiring a U.S. Agent under FDA FSVP regulations
• Businesses needing an ongoing Qualified Individual (QI) for active compliance management
• Multi-supplier or multi-product importers seeking consistent verification and oversight
• Companies preparing for FDA audits, import entry reviews, or FSVP inspections
• Businesses needing an ongoing Qualified Individual (QI) for active compliance management
• Multi-supplier or multi-product importers seeking consistent verification and oversight
• Companies preparing for FDA audits, import entry reviews, or FSVP inspections
How It Works
1. Subscribe monthly based on your enterprise, supplier, and product coverage.
2. Assign your dedicated FSVP-QI and U.S. Agent to manage compliance activities.
3. Receive monthly updates, verification records, and compliance reports.
4. Stay continuously audit-ready with documentation that meets FDA standards.
2. Assign your dedicated FSVP-QI and U.S. Agent to manage compliance activities.
3. Receive monthly updates, verification records, and compliance reports.
4. Stay continuously audit-ready with documentation that meets FDA standards.
Ready to Get Started?
Let our experts handle your FSVP and U.S. Agent responsibilities while you focus on growing your business.
Build a compliant, inspection-ready import program — efficiently, affordably, and professionally.
