FSVP Agent Representation Support
FSVP Agent Services Under 21 CFR 1.500–1.514
Consultare Inc. Group provides FSVP Agent Representation services for foreign suppliers, exporters, and U.S. importers requiring a U.S.-based point of contact for FDA communications and FSVP-related coordination, as permitted under 21 CFR Part 1 Subpart L.
These services are limited to communication facilitation, coordination, and representational support and do not constitute acting as the Importer of Record (IOR) or FSVP Qualified Individual (QI) unless expressly agreed to under a separate written agreement.
Purpose of Service
To serve as a designated FSVP Agent and U.S. Agent for FDA communications, supporting the orderly handling of FDA correspondence, shipment-related FSVP inquiries, and coordination of documentation flow between the Client and U.S. regulatory authorities.
Scope of FSVP Agent Services
1. U.S. Agent Designation for FDA Communications
(Communication Handling Only)
- Act as the Client’s designated U.S. Agent for FDA-registered facilities, solely for the purpose of receiving FDA correspondence related to product import clearance and regulatory communication.
- Receive FDA notifications, inquiries, notices of action, and inspection-related communications.
- Promptly forward all FDA communications to the Client or the Client’s designated representative without assessment, interpretation, or regulatory determination.
2. FSVP Agent Representation (Coordination & Facilitation Only)
Consultare Inc. Group acts as the Client’s FSVP Agent for representation and coordination purposes, as permitted under 21 CFR Part 1 Subpart L.
FSVP Agent services may include, as applicable:
- Acting as the primary FDA point of contact for FSVP-related communications
- Receiving and relaying FDA inquiries or document requests related to FSVP
- Coordinating FDA inspection or information requests with the Client
- Facilitating the collection, organization, and submission of FSVP records provided by the Client, including:
- Hazard analyses
- Supplier records
- Shipment records
- Corrective action documentation
- Coordinating updates to FSVP files based on shipment activity or regulatory requests
- Supporting shipment-specific FSVP verification inquiries
- Coordinating with the Client’s designated FSVP Qualified Individual (QI), when applicable
Important: These services do not include FSVP execution, verification, approval, or compliance decision-making.
2.1 FSVP Agent Authorization Letter – Per Shipment
For shipment-based engagements, Consultare Inc. Group issues a Letter of Authorization – FSVP Agent Representation (Per Shipment) confirming acceptance of FSVP Agent designation for a specifically identified shipment.
- Valid only for the shipment identified in the letter
- Effective until shipment clearance and resolution of related FDA communications
- Intended to satisfy documentation requests commonly made by FDA, customs authorities, couriers, or freight forwarders
Issuance of a Letter of Authorization does not:
- Designate Consultare Inc. Group as the FSVP Importer, IOR, manufacturer, packer, or distributor
- Transfer legal or regulatory responsibility
- Establish standing or multi-shipment representation unless expressly agreed in writing
3. Limited Remote Support
- Up to one (1) hour of remote support per two (2) months for shipment-level logistics, broker coordination, or FDA/USDA-related inquiries.
- Additional support, expedited handling, or substantive compliance activities require separate written authorization and may be billed separately.
4. Regulatory Information & Coordination Support
- Facilitation of FSVP-related reference or verification information
- Coordination with the Client’s designated FSVP Qualified Individual (QI), when applicable
- Support limited strictly to communication and coordination
5. Compliance Calendar & Registration Reminders (If Applicable)
- Courtesy reminders for biennial FDA food facility registration renewals
- Advance notification of known regulatory deadlines (minimum 30 days when applicable)
Reminders are informational only and do not relieve the Client of legal obligations.
Service Limitations (Summary)
FSVP Agent services are strictly limited to representation, communication handling, and coordination.
Services do not include:
- Acting as the FSVP Importer or Importer of Record
- Acting as FSVP Qualified Individual (QI)
- Compliance execution, verification, or approval
- Hazard analysis, SOP development, or shipment authorization
- Customs brokerage services
- Guarantees of FDA clearance or admissibility
The Client remains fully responsible for:
- FSVP compliance under 21 CFR Part 1 Subpart L
- Accuracy and completeness of all records
- Any enforcement actions arising from non-compliance
Fees & Service Options
Fees exclude FSVP QI services, IOR services, escrow arrangements, compliance execution, or customs broker services unless separately contracted.
Expedited & After-Hours Support (Optional)
- Expedited / Same-Day Handling: +30% surcharge
- After-Hours / Weekend Requests: $75 per request
All fees are prepaid and non-refundable.
Ideal For
- Foreign food, beverage, dietary supplement, and ingredient suppliers
- Exporters shipping to the U.S. without a permanent U.S. presence
- Importers requiring a U.S.-based FSVP Agent for FDA communications
- Companies needing shipment-level FSVP Agent authorization letters
Service Activation Timeline
- Per Shipment: Typically within 48 hours of completed onboarding and payment
Emergency Activation: Available for time-sensitive shipments (subject to approval)
Regulatory References
- 21 CFR 1.500–1.514 – Foreign Supplier Verification Program
- 21 CFR 1 Subpart L – FSVP Requirements
- 21 CFR 1.509 – Import Entry Information
- FDA Guidance for Industry: FSVP for Importers of Food
