FSVPQI / U.S. Agent Representation Services
Regulatory Representation Based on 21 CFR 1.500–1.514 and FDA Guidance for Foreign Supplier Verification Program
To establish and maintain compliance representation for foreign food facilities under the U.S. FDA’s Foreign Supplier Verification Program (FSVP), Consultare Inc. Group provides qualified individual (QI) and U.S. Agent services to ensure ongoing regulatory communication, emergency response facilitation, and document management in alignment with 21 CFR 1.509 and related sections.
Scope of Work
U.S. Agent Appointment & Regulatory Liaison
Serve as the officially designated U.S. Agent for the foreign facility as required by FDA regulations. Responsibilities include:
- • Acting as the primary point of contact for the FDA on behalf of the foreign supplier.
- • Receiving and forwarding FDA communications including inspection notices, warning letters, and compliance actions.
- • Ensuring all updates to facility contact and U.S. agent details are promptly submitted to the FDA.
FDA Inspection and Enforcement Support
Provide essential representation and support in case of inspections, recalls, or regulatory enforcement actions:
- • Notify the foreign entity upon FDA’s notice of inspection.
- • Assist in coordinating facility access, logistics, and inspection readiness.
- • Serve as point of contact during food safety incidents, including detentions and recalls, and support communication with U.S. stakeholders and authorities.
FSVP Compliance Communication Management
Support the foreign facility’s FSVP compliance obligations by:
- • Facilitating document transmittal (e.g., hazard analyses, food safety plans, third-party certifications).
- • Supporting timely responses to FDA document requests or compliance follow-ups.
- • Coordinating information exchange with U.S. importers or FSVP agents.
Emergency Notifications & Risk Communication
Ensure regulatory and public health-related information is relayed without delay in critical events:
- • Manage emergency notification protocols during food safety events.
- • Facilitate communication with affected U.S. partners and certification bodies during incidents involving recalls or public health risk.
Additional Services (Optional)
Provide additional agent services as mutually agreed upon in writing.
Deliverables
Regulatory Liaison and Agent Representation
Continuous coverage as designated U.S. Agent for the foreign facility.
FDA Communication Support
Prompt handling and forwarding of official notices, compliance requests, and enforcement documents.
Emergency Notification Protocols
Action-ready framework for recalls, detentions, and contamination events.
FSVP Document Transmittal Support
Document intake and relay for FSVP verification purposes.
Annual Confirmation and Update Review
Annual review of agent information and regulatory contact data with confirmation of continued compliance.
Fees and Subscriptions
Annual Agent Representation Subscription – $199.00 USD / per facility
Includes:
- • Appointment as U.S. Agent under FDA requirements
- • Receipt and relay of FDA communications
- • Enforcement and emergency coordination
- • Support for FSVP document transmittal
- • Annual contact review and confirmation
Add-Ons (As Needed):
• Additional Facilities: +$199/facility/year
• FSVP Document Review Support: +$250/document set
• Recall Notification Assistance: +$500/incident
• Facility Inspection Preparation Support: +$1500/prep cycle
Ideal For:
Foreign food manufacturers, processors, or suppliers exporting to the United States who are required to designate a U.S.-based agent under FDA regulations for FSVP or food facility registration purposes.