FSVP/IMPORTER OF RECORD (IOR) – SHIPMENT INTAKE FORM
Consultare Inc. Group
REGULATORY COMPLIANCE STATEMENT (Required Notice)
This form is required to ensure that all imported products meet U.S. CBP, FDA, USDA, EPA, and FSVP regulatory requirements. It allows Consultare Inc. Group to verify importer responsibility, validate supplier and product compliance, assess food safety and regulatory risks, and maintain complete documentation for customs entry, FSVP review, and audit readiness.
SECTION 1 — SHIPMENT IDENTIFICATION
• Plan to Ship Date/Shipped Date
• Shipment Reference No.
• PO / Invoice No.
• Date Submitted
• Completed By (Name)
• Email
SECTION 2 — IMPORTER INFORMATION
IOR Information
- • Consultare Inc. Group Yes/No
- • Importer of Record
- • IOR Address
- • IOR Contact Person
- • Phone
- • IOR DUNS Number
Customs Broker Information
- • Consultare Inc. Group Yes/No
- • Broker Company Name
- • Broker Address
- • Broker Contact Person
- • Phone
- • Broker DUNS Number
SECTION 3 — SUPPLIER / EXPORTER INFORMATION
• Supplier / Manufacturer Name
• Supplier Address
• Exporting Country
• Supplier Contact Person
• Email
• Phone
• FDA Registration Number (if applicable)
SECTION 4 — U.S. AGENT INFORMATION
Note: This section is required for foreign facilities exporting FDA-regulated products.
SECTION 5 — PRODUCT DETAILS (Supports Multiple Products)
• Product Name(s)
• Product Description(s)
• SKU Number(s)
• HS Code(s)
5.1 FDA Product Category (select all that apply)
(Complete only if product(s) are regulated by FDA.)
FSVP applies to: Food, Dietary Supplements (regulated as food under FSMA), Food Contact Materials. FSVP does NOT apply to: Cosmetics, Medical Devices, Drugs
Category
• Food
• Dietary Supplement
• Cosmetic
• Medical Device
• Drug
• Food Contact Material
• Others
Additional Product Information
• Ingredient List
• Allergens
SECTION 6 — SHIPMENT LOGISTICS
• Mode of Transport (Land, Air, Sea, via Courier)
• U.S. Port of Entry
• Estimated Arrival Date
• Quantity / Weight
• No. of Packages / Pallets
• Packaging Type
• Temperature Control (Ambient / Refrigerated / Frozen)
• Wood packaging used
SECTION 7 — CBP ENTRY REQUIREMENTS
• Shipment’s Commercial Invoice
• Shipment’s Packing List
• Shipment’s Bill of Lading / Airway Bill
• Country of Origin Marking
• HS Code Classification
• Antidumping and Countervailing Duties
• AD/CVD
• Forced Labor (UFLPA) Review
SECTION 8 — FDA REQUIREMENTS
• FDA Facility Registration No. (Supplier / Manufacturer)
• Prior Notice
SECTION 9 — USDA REQUIREMENTS
9.1 USDA-regulated commodities in the shipment
• Phytosanitary Certificate
• APHIS PPQ 587 Permit
• Veterinary Permit
• ISPM-15 Verification
• Others
9.2 Is the entity licensing the import of the USDA-regulated commodity(ies) already formed/established within the United States? (Yes/No) _________
SECTION 10 — EPA / TSCA REQUIREMENTS
TSCA Applicability: TSCA does not apply to Food, Dietary Supplements, Drugs, Medical Devices, or Cosmetics. TSCA may apply to certain Food Contact Materials, such as plastics, resins, coatings, chemical treatments, antimicrobial-treated packaging, PFAS-related substances, or other chemical-based components.
• EPA / TSCA Certificate
SECTION 11 — FOOD SAFETY / FSVP DOCUMENT CHECKLIST
• Facility registration
• HACCP/Food Safety Plan/Preventive Controls
• GMP certificates
• Third-party audit certificate/report
• Supplier questionnaire
• Hazard Analysis
• Process flow diagram
• Corrective actions
• Allergen Statement
• Product Specification Sheet
• COA / Laboratory Testing
• Recall Plan
• Lot Coding / Traceability
• Shelf-Life Documentation
• Sanitary Transportation Confirmation
SECTION 12 — RISK ASSESSMENT
(To be completed by Consultare Inc. Group - Compliance Team)
• Supplier Approval
• Food Safety Risk
• Label Compliance
• FSVP Risk
• Regulatory Risk
• Missing Documents
SECTION 13 — FSVPQI EVALUATION & VERIFICATION ACTIVITIES
(To be completed by FSVP Qualified Individual)
A. Supplier Evaluation Activities
• Review of Supplier Hazard Analysis
• Hazard Assessment (Biological, Chemical, Physical)
• Review of Preventive Controls / HARPC / HACCP
• Evaluation of Supplier Food Safety Controls
• Review of Supplier FDA Compliance History
• Review of Import Alerts / Warning Letters / 483s
• Assessment of Corrective Actions
B. Verification Activities Performed
• COA Review
• Third-Party Lab Testing
• Environmental Monitoring
• Batch / Production Record Review
• Allergen Control Review
• Sanitary Transportation Review
• Sampling / Inspection
• Prior Non-Conformance Review
• On-site Audit (if required)
C. Supply-Chain Program Activities
• Supplier Approval
• Supply-Chain Documentation
• Qualification Status
• Packaging & Label Compliance
• Traceability / Lot Coding
• Cold Chain Compliance
D. FSVPQI Determinations
• Verification frequency
• Justification based on risk level
• Additional Controls
• Shipment Reviewed for trigger events
• Reanalysis
E. Final FSVPQI Approval
• FSVP QI Name
• Signature
• Authorization Tracking No.
• Date reviewed
• Status (Approved / Approved w/ Conditions / Not Approved)
SECTION 14 — FINAL REVIEW & APPROVAL
(To be filled out by Compliance Department)
• Reviewed by
• Signature
• Authorization Tracking No.
• Date reviewed
• Corrective Action/s Required
SECTION 15 — FSVP SERVICE FEES
To support compliance under 21 CFR 1 Subpart L – Foreign Supplier Verification Programs (FSVP), Consultare Inc. Group applies service fees based on the scope of verification activities required for each supplier, product (SKU), and shipment. These fees cover the work performed by the FSVP Importer and the FSVP Qualified Individual (QI) to ensure full regulatory compliance and audit readiness.
Please note that the fees quoted herein are not mandatory, but may be availed upon request.
15.1 IOR/FSVP Importer Service Fees (per shipment) - $360 per shipment, or $750 per month (up to 10 shipments per month)
Includes compliance activities required to support Importer of Record (IOR) responsibilities and shipment-level regulatory verification:
• Importer of Record (IOR) Regulatory Designation
Oversight of compliance requirements associated with IOR responsibilities, including shipment-level documentation review and regulatory coordination.
• Entry Prior Notice Coordination & Verification
Submission review, validation of confirmation numbers, and coordination with the customs broker to ensure accurate Prior Notice entries.
• Remote Compliance Support (Up to 3 Hours per Shipment)
Guidance on documentation, regulatory questions, product classifications, and shipment-specific compliance requirements.
• Shipment Documentation Collection
Gathering and verifying all required documents to support CBP and FDA entry processing, including:
Verification of batch, lot, and production documentation required for FDA/FSVP alignment.
• Traceability & Lot Coding Assessment
Review of traceability design, lot coding, and related records to support FSMA traceability and import compliance.
• Sanitary Transportation Documentation Review
Ensuring compliance with FDA’s Sanitary Transportation Rule under 21 CFR Part 1, Subpart O.
• Risk Assessment
Assessment of shipment-level risk based on documentation, product category, foreign supplier history, and commodity type.
• Recordkeeping & Traceability Management
Ensuring proper documentation retention aligned with FDA FSVP requirements and audit readiness.
Note: Additional fees may apply for high-risk commodities, incomplete or missing documents, absent COAs, label reviews, or shipments requiring extended corrective action support.
Q: Does the Importer of Record need to be located in the U.S.?
A: Importer of Record (IOR) – Must be a legal entity or person based in the U.S. The IOR is legally responsible for ensuring that imported products comply with all U.S. laws and regulations, paying duties and tariffs, maintaining proper records, and providing documentation during inspections or audits.
• Importer of Record (IOR) Regulatory Designation
Oversight of compliance requirements associated with IOR responsibilities, including shipment-level documentation review and regulatory coordination.
• Entry Prior Notice Coordination & Verification
Submission review, validation of confirmation numbers, and coordination with the customs broker to ensure accurate Prior Notice entries.
• Remote Compliance Support (Up to 3 Hours per Shipment)
Guidance on documentation, regulatory questions, product classifications, and shipment-specific compliance requirements.
• Shipment Documentation Collection
Gathering and verifying all required documents to support CBP and FDA entry processing, including:
◦ Commercial Invoice
◦ Packing List
◦ Bill of Lading or Airway Bill
◦ Country of Origin Statements
◦ Certificates of Analysis (when applicable)
◦ Certificate of Free Sale (if required)
• Batch Documentation Assessment
◦ Packing List
◦ Bill of Lading or Airway Bill
◦ Country of Origin Statements
◦ Certificates of Analysis (when applicable)
◦ Certificate of Free Sale (if required)
Verification of batch, lot, and production documentation required for FDA/FSVP alignment.
• Traceability & Lot Coding Assessment
Review of traceability design, lot coding, and related records to support FSMA traceability and import compliance.
• Sanitary Transportation Documentation Review
Ensuring compliance with FDA’s Sanitary Transportation Rule under 21 CFR Part 1, Subpart O.
• Risk Assessment
Assessment of shipment-level risk based on documentation, product category, foreign supplier history, and commodity type.
• Recordkeeping & Traceability Management
Ensuring proper documentation retention aligned with FDA FSVP requirements and audit readiness.
Note: Additional fees may apply for high-risk commodities, incomplete or missing documents, absent COAs, label reviews, or shipments requiring extended corrective action support.
Q: Does the Importer of Record need to be located in the U.S.?
A: Importer of Record (IOR) – Must be a legal entity or person based in the U.S. The IOR is legally responsible for ensuring that imported products comply with all U.S. laws and regulations, paying duties and tariffs, maintaining proper records, and providing documentation during inspections or audits.
15.2 Per-supplier Fees - $540 per supplier per annum (FSVP setup with annual maintenance)
Fee may vary depending on category, unit sizes, and unit presentations.
Includes setup, evaluation, and ongoing review of supplier-level compliance under FSVP requirements, including:
• Supplier Hazard Analysis
Evaluation of potential hazards related to the supplier’s processes, environment, and product categories to identify risks that could affect imported food safety.
• Evaluation of Food Safety Controls
Assessment of preventive controls, sanitation programs, and risk-based mitigation strategies implemented by the supplier to ensure regulatory compliance.
• FDA Compliance History Review
Analysis of the supplier’s past FDA compliance, inspection records, and overall regulatory performance to identify potential risk areas.
• Import Alert & Warning Letter Screening
Checking suppliers and facilities against FDA import alerts, warning letters, refusals, and enforcement records to prevent non-compliant shipments.
• Certification & Regulatory Documentation Review
Verification of third-party certifications, Certificates of Analysis (COAs), and other regulatory documentation to ensure completeness and validity.
• Corrective Action Evaluation
Review of corrective actions implemented in response to deviations, complaints, or audit findings, and assessing their effectiveness.
• Verification Activity Plan & Frequency Determination
Developing a risk-based verification plan, defining the required verification steps, and determining the appropriate frequency of review for each supplier.
• Annual FSVP Reanalysis
Conducting a comprehensive yearly review of all supplier data, hazard analyses, and verification activities in accordance with 21 CFR 1.505 to ensure ongoing compliance.
• Supplier Hazard Analysis
Evaluation of potential hazards related to the supplier’s processes, environment, and product categories to identify risks that could affect imported food safety.
• Evaluation of Food Safety Controls
Assessment of preventive controls, sanitation programs, and risk-based mitigation strategies implemented by the supplier to ensure regulatory compliance.
• FDA Compliance History Review
Analysis of the supplier’s past FDA compliance, inspection records, and overall regulatory performance to identify potential risk areas.
• Import Alert & Warning Letter Screening
Checking suppliers and facilities against FDA import alerts, warning letters, refusals, and enforcement records to prevent non-compliant shipments.
• Certification & Regulatory Documentation Review
Verification of third-party certifications, Certificates of Analysis (COAs), and other regulatory documentation to ensure completeness and validity.
• Corrective Action Evaluation
Review of corrective actions implemented in response to deviations, complaints, or audit findings, and assessing their effectiveness.
• Verification Activity Plan & Frequency Determination
Developing a risk-based verification plan, defining the required verification steps, and determining the appropriate frequency of review for each supplier.
• Annual FSVP Reanalysis
Conducting a comprehensive yearly review of all supplier data, hazard analyses, and verification activities in accordance with 21 CFR 1.505 to ensure ongoing compliance.
Includes setup, review, and ongoing maintenance of product-level compliance activities required under FDA FSVP regulations limited to:
• Product Hazard Analysis
Evaluation of potential biological, chemical, and physical hazards associated with each individual product, formulation, and intended use.
• Ingredient and Allergen Review
Assessment of ingredients, allergen declarations, and cross-contact risks to ensure compliance with U.S. labeling and safety requirements.
• Product Specification Review
Verification of product specifications, quality parameters, COAs, and related documentation to ensure accuracy and regulatory consistency.
• Risk Level Determination
Assigning a risk category (low/medium/high) based on product type, process controls, supplier performance, and historical compliance data.
• Verification Activity Planning
Establishing appropriate verification steps, such as COA review, batch documentation, supplier audits, or testing, and defining required frequency.
• Annual Reanalysis (if applicable)
Reviewing and updating the product-specific hazard analysis, risk level, and verification activities annually or when new information becomes available, as required under 21 CFR 1.505.
• Product Hazard Analysis
Evaluation of potential biological, chemical, and physical hazards associated with each individual product, formulation, and intended use.
• Ingredient and Allergen Review
Assessment of ingredients, allergen declarations, and cross-contact risks to ensure compliance with U.S. labeling and safety requirements.
• Product Specification Review
Verification of product specifications, quality parameters, COAs, and related documentation to ensure accuracy and regulatory consistency.
• Risk Level Determination
Assigning a risk category (low/medium/high) based on product type, process controls, supplier performance, and historical compliance data.
• Verification Activity Planning
Establishing appropriate verification steps, such as COA review, batch documentation, supplier audits, or testing, and defining required frequency.
• Annual Reanalysis (if applicable)
Reviewing and updating the product-specific hazard analysis, risk level, and verification activities annually or when new information becomes available, as required under 21 CFR 1.505.
15.2.1 Per-SKU Fees — $270 per SKU / per annum
(FSVP setup with annual maintenance. Final fees may vary depending on product category, unit sizes, and unit presentations.) Includes setup, review, and ongoing maintenance of product-level compliance activities required under FDA FSVP regulations, limited to: • Product Hazard Analysis
Evaluation of potential biological, chemical, and physical hazards associated with each individual product, formulation, processing method, and intended use. • Ingredient and Allergen Review
Assessment of ingredient composition, allergen declarations, and cross-contact risks to ensure compliance with U.S. food labeling and safety requirements. • Product Specification Review
Verification of specifications, quality parameters, Certificates of Analysis (COAs), and supporting documentation to ensure accuracy, completeness, and regulatory alignment. • Risk Level Determination
Classification of each product into a risk category (low/medium/high) based on product type, processing controls, supplier performance, historical compliance data, and known hazards. • Verification Activity Planning
Development of appropriate verification steps—such as COA review, batch documentation, supplier audits, laboratory testing, or other risk-based activities—and determination of required frequency. • Annual Reanalysis (if applicable)
Reevaluation and update of the product-specific hazard analysis, risk category, and verification activities on an annual basis or when new information becomes available, as required under 21 CFR 1.505. Q: If I have multiple SKUs, am I eligible for a discounted rate on the per-SKU fee?
A: Yes. Clients with multiple SKUs may qualify for a discounted rate. Pricing may vary depending on the product category, unit sizes, formulations, and overall complexity. We will prepare a customized fee package once all product details have been reviewed.
(FSVP setup with annual maintenance. Final fees may vary depending on product category, unit sizes, and unit presentations.) Includes setup, review, and ongoing maintenance of product-level compliance activities required under FDA FSVP regulations, limited to: • Product Hazard Analysis
Evaluation of potential biological, chemical, and physical hazards associated with each individual product, formulation, processing method, and intended use. • Ingredient and Allergen Review
Assessment of ingredient composition, allergen declarations, and cross-contact risks to ensure compliance with U.S. food labeling and safety requirements. • Product Specification Review
Verification of specifications, quality parameters, Certificates of Analysis (COAs), and supporting documentation to ensure accuracy, completeness, and regulatory alignment. • Risk Level Determination
Classification of each product into a risk category (low/medium/high) based on product type, processing controls, supplier performance, historical compliance data, and known hazards. • Verification Activity Planning
Development of appropriate verification steps—such as COA review, batch documentation, supplier audits, laboratory testing, or other risk-based activities—and determination of required frequency. • Annual Reanalysis (if applicable)
Reevaluation and update of the product-specific hazard analysis, risk category, and verification activities on an annual basis or when new information becomes available, as required under 21 CFR 1.505. Q: If I have multiple SKUs, am I eligible for a discounted rate on the per-SKU fee?
A: Yes. Clients with multiple SKUs may qualify for a discounted rate. Pricing may vary depending on the product category, unit sizes, formulations, and overall complexity. We will prepare a customized fee package once all product details have been reviewed.
15.3 Per-supplier Fees – $540 per supplier per annum (FSVP setup with annual maintenance)
15.3 US Agent/FSVP Agent Representation - $75 per month or $810 per annum.
Consultare Inc. Group provides U.S. Agent and FSVP Agent Representation to support foreign suppliers and U.S. importers in meeting FDA and FSMA requirements. Services include:
• U.S. Agent Designation & FDA Communications Handling
Acting as the formal U.S. Agent for FDA communications, receiving notices, inquiries, and regulatory correspondence on behalf of the foreign facility or brand owner.
• FSVP Agent Representation (communication point only)
Acting as the listed FSVP Agent for FDA records and communications. This service does not include FSVP QI review, verification activities, hazard analysis, or shipment approvals.
• Compliance Calendar & FDA Registration Monitoring
Tracking renewal dates, biennial registration deadlines, and required compliance activities through a centralized compliance calendar.
• Document Receipt and File Routing (representation only)
Receiving FDA-related documentation and forwarding it to the client or their designated compliance personnel. No compliance review, approval, or evaluation is included.
• Quarterly Representation Summary
A brief quarterly summary of any FDA correspondence received and status of required FDA-related notifications.
• Important Note
This service provides representation only and does not include any compliance execution, verification, review, hazard analysis, SOP support, shipment approvals, or QI responsibilities under 21 CFR 1 Subpart L.
Q: Does it matter if I have 1 or over 100 products, does this cover under the US Agent/FSVP Agent Representation services?
A: This service is a representation-only function. It covers FDA communications, acting as the listed U.S. Agent or FSVP Agent, maintaining compliance calendars, and routing documents — regardless of whether you have 1 product or over 100 products.
• U.S. Agent Designation & FDA Communications Handling
Acting as the formal U.S. Agent for FDA communications, receiving notices, inquiries, and regulatory correspondence on behalf of the foreign facility or brand owner.
• FSVP Agent Representation (communication point only)
Acting as the listed FSVP Agent for FDA records and communications. This service does not include FSVP QI review, verification activities, hazard analysis, or shipment approvals.
• Compliance Calendar & FDA Registration Monitoring
Tracking renewal dates, biennial registration deadlines, and required compliance activities through a centralized compliance calendar.
• Document Receipt and File Routing (representation only)
Receiving FDA-related documentation and forwarding it to the client or their designated compliance personnel. No compliance review, approval, or evaluation is included.
• Quarterly Representation Summary
A brief quarterly summary of any FDA correspondence received and status of required FDA-related notifications.
• Important Note
This service provides representation only and does not include any compliance execution, verification, review, hazard analysis, SOP support, shipment approvals, or QI responsibilities under 21 CFR 1 Subpart L.
Q: Does it matter if I have 1 or over 100 products, does this cover under the US Agent/FSVP Agent Representation services?
A: This service is a representation-only function. It covers FDA communications, acting as the listed U.S. Agent or FSVP Agent, maintaining compliance calendars, and routing documents — regardless of whether you have 1 product or over 100 products.
15.4 Custom Broker Facilitation Services - $149 per entry
Consultare Inc. Group acts strictly as a communication and coordination facilitator between the client and their designated customs broker. We do not provide customs brokerage services. Service includes:
• Liaison with Client’s Assigned Customs Broker
Facilitating communication by sharing documents, clarifying information, and relaying updates.
• Shipment Status Updates
Notifying the client of customs broker updates regarding holds, release status, or needed documentation.
• Responding to Broker Information Requests
Providing supporting documentation facilitation such as Prior Notice confirmation, product details, or FSVP status information.
• Entry Documentation Coordination
Facilitating the coordination of all documents submitted to Consultare Inc. Group (invoice, packing list, COA, labels, etc.) as provided by the supplier or importer, per customs broker request.
• FSVP/Regulatory Information Support (facilitation only)
Supplying the customs broker with verification information related to FSVP compliance, when applicable.
• Monitoring FDA/CBP Communication (facilitation only)
Monitoring for FDA requests or clarification notices (as relayed through the customs broker) and informing the client.
• Discrepancy Relay
Communicating any documentation inconsistencies identified by the customs broker and coordinating with the client to correct them.
• Exam/Inspection Coordination (communication only)
Relaying notices, updates, and instructions from the customs broker related to examinations or inspections.
• Liaison with Client’s Assigned Customs Broker
Facilitating communication by sharing documents, clarifying information, and relaying updates.
• Shipment Status Updates
Notifying the client of customs broker updates regarding holds, release status, or needed documentation.
• Responding to Broker Information Requests
Providing supporting documentation facilitation such as Prior Notice confirmation, product details, or FSVP status information.
• Entry Documentation Coordination
Facilitating the coordination of all documents submitted to Consultare Inc. Group (invoice, packing list, COA, labels, etc.) as provided by the supplier or importer, per customs broker request.
• FSVP/Regulatory Information Support (facilitation only)
Supplying the customs broker with verification information related to FSVP compliance, when applicable.
• Monitoring FDA/CBP Communication (facilitation only)
Monitoring for FDA requests or clarification notices (as relayed through the customs broker) and informing the client.
• Discrepancy Relay
Communicating any documentation inconsistencies identified by the customs broker and coordinating with the client to correct them.
• Exam/Inspection Coordination (communication only)
Relaying notices, updates, and instructions from the customs broker related to examinations or inspections.
15.5 Additional / Optional Fees
The following optional services support enhanced verification, specialized assessments, and audit readiness activities beyond standard FSVP requirements. These services may be added as needed based on product risk, supplier performance, or regulatory demands:
• 15.5.1 U.S. FDA Food Facility Registration – $550 per facility
Complete facilitation of FDA registration for your manufacturing or distribution facilities to ensure compliance with U.S. federal requirements.
• 15.5.2 D-U-N-S Number Registration – $190 per facility
Assistance with obtaining a D-U-N-S number for your facility, required for FDA registration and verification with U.S. and global partners.
• 15.5.3 FDA Prior Notice Filing – Custom Quote (case-to-case basis)
Preparation and submission of FDA Prior Notice for incoming food shipments, with pricing determined based on shipment size, number of line items, and commodity variations.
• 15.5.4 FSVP Onsite Support (FDA/FSIS Audit) – $1,200 per day + travel, lodging, meals
In-person regulatory support during FDA or FSIS inspections, including document presentation, audit navigation assistance, and real-time compliance guidance.
• 15.5.5 HACCP/Food Safety Plan/Preventive Controls Development – $2,900 per product category
Creation of a compliant HACCP/Food Safety/Preventive Control Plan, including hazard analysis and preventive controls, tailored to each specific product category under FDA requirements.
• 15.5.6 Supplier Gap Assessment – $550 per supplier
Comprehensive evaluation of a supplier’s food safety program to identify deficiencies, verify compliance with 21 CFR 117/1 Subpart L, and determine corrective action needs.
• 15.5.7 Certificate of Analysis (COA) / Laboratory Report Interpretation – $45 per document
Technical review of laboratory results, ensuring proper test methods, regulatory thresholds, contaminant levels, and alignment with product specifications.
• 15.5.8 Harmonized System (HS) Code Lookup Service – starts at $99 per commodity
Assistance in determining the correct HS code for your product to ensure accurate classification for import and export requirements.
• 15.5.9 Environmental Monitoring Review – $85 per batch
Verification of environmental testing results for Listeria, Salmonella, allergen residues, and hygiene indicators as part of ongoing risk-based verification.
• 15.5.10 Label Regulatory Compliance Review (21 CFR Part 101) – $750 per label / $650 per additional label
FDA regulatory assessment of product labels, including Nutrition/Supplement Facts formatting, ingredient statements, allergen declarations, claims review, and format compliance.
• 15.5.11 Nutrition Facts / Supplement Facts Panel Review (format + content validation) – $425 per panel / $350 per additional panel
Comprehensive FDA compliance review of format and content, including nutrient validation against client-provided formula, COA, or test data, serving size accuracy, %DV calculations, layout and formatting checks, and mandatory/voluntary nutrient placement.
• 15.5.12 GS1 Barcode / GTIN Setup / SKU Number – $50 per SKU (facilitation only) (GS1 fees excluded)
Full facilitation of GS1 company prefix registration, GTIN assignment and purchase, barcode generation.
• 15.5.13 GS1 Barcode / GTIN / SKU Number Annual Maintenance – $35 per year (1 SKU), $15 per additional SKU (GS1 fees excluded)
Annual review and update of GTINs and barcode files, GS1 prefix renewals.
• 15.5.14 Emergency / Expedited FSVPQI Review Service – Custom Quote (case-to-case basis)
Priority processing of urgent documentation reviews, or last-minute regulatory needs required to prevent shipment delays or holds.
• 15.5.15 FDA/FSVP Compliance Programs and Forms Templates – $12 per template
Compliance templates aligned with the regulatory standards, customizable according to your intended process.
• 15.5.16 USDA Import Permit Filing & eFile Setup – $550 per material (initial); $175/year per material for renewal (USDA fees excluded)
Includes eligibility review, eFile account setup (for initial submission), PPQ 587 preparation, submission, correspondence handling, and issuance support.
• 15.5.17 U.S. Entity Incorporation/Formation Application Services – $550.00 per submission
(State filing fees, postal/courier charges, and any expedited State processing fees excluded)
Assessment of company availability within chosen State of incorporation/formation, agent facilitation (for foreign entities), application submission, and regulatory approval correspondence tracking.
• 15.5.1 U.S. FDA Food Facility Registration – $550 per facility
Complete facilitation of FDA registration for your manufacturing or distribution facilities to ensure compliance with U.S. federal requirements.
• 15.5.2 D-U-N-S Number Registration – $190 per facility
Assistance with obtaining a D-U-N-S number for your facility, required for FDA registration and verification with U.S. and global partners.
• 15.5.3 FDA Prior Notice Filing – Custom Quote (case-to-case basis)
Preparation and submission of FDA Prior Notice for incoming food shipments, with pricing determined based on shipment size, number of line items, and commodity variations.
• 15.5.4 FSVP Onsite Support (FDA/FSIS Audit) – $1,200 per day + travel, lodging, meals
In-person regulatory support during FDA or FSIS inspections, including document presentation, audit navigation assistance, and real-time compliance guidance.
• 15.5.5 HACCP/Food Safety Plan/Preventive Controls Development – $2,900 per product category
Creation of a compliant HACCP/Food Safety/Preventive Control Plan, including hazard analysis and preventive controls, tailored to each specific product category under FDA requirements.
• 15.5.6 Supplier Gap Assessment – $550 per supplier
Comprehensive evaluation of a supplier’s food safety program to identify deficiencies, verify compliance with 21 CFR 117/1 Subpart L, and determine corrective action needs.
• 15.5.7 Certificate of Analysis (COA) / Laboratory Report Interpretation – $45 per document
Technical review of laboratory results, ensuring proper test methods, regulatory thresholds, contaminant levels, and alignment with product specifications.
• 15.5.8 Harmonized System (HS) Code Lookup Service – starts at $99 per commodity
Assistance in determining the correct HS code for your product to ensure accurate classification for import and export requirements.
• 15.5.9 Environmental Monitoring Review – $85 per batch
Verification of environmental testing results for Listeria, Salmonella, allergen residues, and hygiene indicators as part of ongoing risk-based verification.
• 15.5.10 Label Regulatory Compliance Review (21 CFR Part 101) – $750 per label / $650 per additional label
FDA regulatory assessment of product labels, including Nutrition/Supplement Facts formatting, ingredient statements, allergen declarations, claims review, and format compliance.
• 15.5.11 Nutrition Facts / Supplement Facts Panel Review (format + content validation) – $425 per panel / $350 per additional panel
Comprehensive FDA compliance review of format and content, including nutrient validation against client-provided formula, COA, or test data, serving size accuracy, %DV calculations, layout and formatting checks, and mandatory/voluntary nutrient placement.
• 15.5.12 GS1 Barcode / GTIN Setup / SKU Number – $50 per SKU (facilitation only) (GS1 fees excluded)
Full facilitation of GS1 company prefix registration, GTIN assignment and purchase, barcode generation.
• 15.5.13 GS1 Barcode / GTIN / SKU Number Annual Maintenance – $35 per year (1 SKU), $15 per additional SKU (GS1 fees excluded)
Annual review and update of GTINs and barcode files, GS1 prefix renewals.
• 15.5.14 Emergency / Expedited FSVPQI Review Service – Custom Quote (case-to-case basis)
Priority processing of urgent documentation reviews, or last-minute regulatory needs required to prevent shipment delays or holds.
• 15.5.15 FDA/FSVP Compliance Programs and Forms Templates – $12 per template
Compliance templates aligned with the regulatory standards, customizable according to your intended process.
• 15.5.16 USDA Import Permit Filing & eFile Setup – $550 per material (initial); $175/year per material for renewal (USDA fees excluded)
Includes eligibility review, eFile account setup (for initial submission), PPQ 587 preparation, submission, correspondence handling, and issuance support.
• 15.5.17 U.S. Entity Incorporation/Formation Application Services – $550.00 per submission
(State filing fees, postal/courier charges, and any expedited State processing fees excluded)
Assessment of company availability within chosen State of incorporation/formation, agent facilitation (for foreign entities), application submission, and regulatory approval correspondence tracking.
15.6 Billing and Responsibility
FSVP fees are invoiced to the Importer, Shipper, or Authorized Representative prior to any FSVP QI review, approval, or shipment clearance activity. All required forms, documentation, and payments must be completed before Consultare Inc. Group can assume responsibilities as the FSVP Importer or FSVP Qualified Individual (QI).
If required documents or fees are not provided, Consultare Inc. Group cannot perform FSVP Importer or QI duties. In such cases, the shipper assumes full responsibility for all regulatory outcomes, including:
Consultare Inc. Group bears no liability for shipments or entries processed without completed requirements, executed documentation, or confirmed payment.
If required documents or fees are not provided, Consultare Inc. Group cannot perform FSVP Importer or QI duties. In such cases, the shipper assumes full responsibility for all regulatory outcomes, including:
◦ Import refusals
◦ FDA or CBP detentions, holds, or examinations
◦ FDA audits or inspections
◦ Warning letters or regulatory actions
◦ Any non-compliance findings or enforcement outcomes
◦ FDA or CBP detentions, holds, or examinations
◦ FDA audits or inspections
◦ Warning letters or regulatory actions
◦ Any non-compliance findings or enforcement outcomes
Consultare Inc. Group bears no liability for shipments or entries processed without completed requirements, executed documentation, or confirmed payment.
SECTION 16 — FSVP/IOR MANAGEMENT TOOL - MANDATORY
Consultare Inc. Group provides complimentary access to the FSVP IOR Management System Software, powered by InterlinkIQ, to all active FSVP clients. Use of this system is mandatory for all clients receiving FSVP services. This secure, cloud-based platform centralizes supplier onboarding, product hazard analysis, verification activity tracking, shipment-level documentation review, and audit-ready recordkeeping. Mandatory use of this system ensures transparency, strengthens compliance oversight, and maintains complete documentation required under 21 CFR Part 1 Subpart L.
This software is provided at no additional cost as part of your FSVP service subscription. Access is granted exclusively to active FSVP clients and is required to support the ongoing verification activities performed by the FSVP Importer and the FSVP Qualified Individual (QI). Failure to use the system or maintain required documentation within the platform may delay reviews, risk non-compliance, or prevent Consultare Inc. Group from performing its duties as the designated FSVP Importer or FSVP QI.
This software is provided at no additional cost as part of your FSVP service subscription. Access is granted exclusively to active FSVP clients and is required to support the ongoing verification activities performed by the FSVP Importer and the FSVP Qualified Individual (QI). Failure to use the system or maintain required documentation within the platform may delay reviews, risk non-compliance, or prevent Consultare Inc. Group from performing its duties as the designated FSVP Importer or FSVP QI.
SECTION 17 — FSVP/QI COMPLIANCE MANAGEMENT SOFTWARE (RECOMMENDED)
$149 per Month/per User Subscription
Consultare Inc. Group offers access to the FSVP Compliance Management Software, powered by InterlinkIQ, designed to support complete management of all regulatory requirements under 21 CFR Part 1 Subpart L. This cloud-based system provides an organized, automated environment to help importers maintain full Foreign Supplier Verification Program (FSVP) compliance, reduce manual workload, and stay audit-ready at all times.
Although use of the software is is strongly recommended to ensure consistent compliance, streamlined documentation, and improved oversight across all required FSVP elements, including:
Consultare Inc. Group offers access to the FSVP Compliance Management Software, powered by InterlinkIQ, designed to support complete management of all regulatory requirements under 21 CFR Part 1 Subpart L. This cloud-based system provides an organized, automated environment to help importers maintain full Foreign Supplier Verification Program (FSVP) compliance, reduce manual workload, and stay audit-ready at all times.
Although use of the software is is strongly recommended to ensure consistent compliance, streamlined documentation, and improved oversight across all required FSVP elements, including:
Foreign Supplier Verification Program (FSVP) Compliance Management Covered in the System
Clients may choose to upload documentation manually without the system; however, not using the platform may increase review time, risk incomplete documentation, or create delays in FSVP QI approvals and during FSVP audits.
• §1.501 — Products Covered
Classification, tracking, and documentation of all foods subject to FSVP.
• §1.502 — FSVP Requirements
Centralized compliance tasks and verification workflows.
• §1.503 — FSVP Personnel
Assignment and documentation of qualified individuals and responsible parties.
• §1.504 — Hazard Analysis
Automated templates and structured analysis tools for biological, chemical, and physical hazards.
• §1.505 — FSVP Evaluation
Risk-based evaluation logging for suppliers, products, and processes.
• §1.506 — Foreign Supplier Verification
Tracking of verification activities such as audits, sampling, COAs, and corrective action reviews.
• §1.507 — Import Foods Hazard
Documentation of known or foreseeable hazards related to imported foods.
• §1.508 — Corrective Actions
Recording, tracking, and closing of corrective actions linked to suppliers or shipments.
• §1.509 — Importer Identification
Maintenance of importer identity information for entries and records.
• §1.510 — Records
Secure storage of all FSVP documents with audit-ready retention controls.
• §1.511 — Foods Subject to Dietary Supplement Requirements
Tailored workflows for dietary supplements and supplier cGMP conformance.
• §1.512 — Foods From Small Foreign Suppliers
Streamlined documentation requirements and applicable exemptions.
• §1.513 — Foods From Countries With Equivalent Food Safety Systems
Tracking of equivalency programs and supporting documentation.
• §1.514 — Consequences for Failure to Comply
System alerts for missing documents, expired verifications, or compliance gaps.
Classification, tracking, and documentation of all foods subject to FSVP.
• §1.502 — FSVP Requirements
Centralized compliance tasks and verification workflows.
• §1.503 — FSVP Personnel
Assignment and documentation of qualified individuals and responsible parties.
• §1.504 — Hazard Analysis
Automated templates and structured analysis tools for biological, chemical, and physical hazards.
• §1.505 — FSVP Evaluation
Risk-based evaluation logging for suppliers, products, and processes.
• §1.506 — Foreign Supplier Verification
Tracking of verification activities such as audits, sampling, COAs, and corrective action reviews.
• §1.507 — Import Foods Hazard
Documentation of known or foreseeable hazards related to imported foods.
• §1.508 — Corrective Actions
Recording, tracking, and closing of corrective actions linked to suppliers or shipments.
• §1.509 — Importer Identification
Maintenance of importer identity information for entries and records.
• §1.510 — Records
Secure storage of all FSVP documents with audit-ready retention controls.
• §1.511 — Foods Subject to Dietary Supplement Requirements
Tailored workflows for dietary supplements and supplier cGMP conformance.
• §1.512 — Foods From Small Foreign Suppliers
Streamlined documentation requirements and applicable exemptions.
• §1.513 — Foods From Countries With Equivalent Food Safety Systems
Tracking of equivalency programs and supporting documentation.
• §1.514 — Consequences for Failure to Comply
System alerts for missing documents, expired verifications, or compliance gaps.
Clients may choose to upload documentation manually without the system; however, not using the platform may increase review time, risk incomplete documentation, or create delays in FSVP QI approvals and during FSVP audits.
Understanding the Difference: FSVP Agent vs. FSVP Qualified Individual (QI)
Two roles, both important, but very different.
When importing food or dietary supplements into the United States, businesses often hear two terms: FSVP Agent and FSVP Qualified Individual (FSVPQI). Although they sound similar, these roles serve very different purposes in your compliance.
FSVP Agent, your U.S. Representative
An FSVP Agent is your designated representative inside the United States. Their primary duty is to serve as the official point of contact between you and the U.S. FDA.
FSVP Agent
Think of the FSVP Agent as your regulatory “bridge” to the U.S. FDA. However, the FSVP Agent does not perform the technical food safety work required by the regulation.
FSVP Agent
◦ Receives FDA/FSVP calls, notices, and audit requests
◦ Communicates with FDA on your behalf
◦ Helps ensure you understand your obligations
◦ Must have a physical U.S. address and phone number
◦ Communicates with FDA on your behalf
◦ Helps ensure you understand your obligations
◦ Must have a physical U.S. address and phone number
Think of the FSVP Agent as your regulatory “bridge” to the U.S. FDA. However, the FSVP Agent does not perform the technical food safety work required by the regulation.
FSVP Qualified Individual (FSVPQI) — Your Compliance Expert
The FSVPQI is the person who performs the technical work to ensure your products meet FDA safety requirements under 21 CFR 1 Subpart L.
An FSVPQII:
Think of the FSVPQI as your food safety and compliance expert . This role requires education, training, or experience in food safety and hazard evaluation.
An FSVPQII:
◦ Conducts hazard analyses for each product
◦ Evaluates and approves each foreign supplier
◦ Reviews COAs, lab reports, and product documentation
◦ Determines verification activities
◦ Approves shipments for release
◦ Maintains required FSVP records
◦ Represents you during FDA FSVP inspections
◦ Evaluates and approves each foreign supplier
◦ Reviews COAs, lab reports, and product documentation
◦ Determines verification activities
◦ Approves shipments for release
◦ Maintains required FSVP records
◦ Represents you during FDA FSVP inspections
Think of the FSVPQI as your food safety and compliance expert . This role requires education, training, or experience in food safety and hazard evaluation.
| Simple Breakdown | |
|---|---|
|
FSVP Agent = U.S. Representative
Handles FDA communications.
|
FSVPQI = Technical Expert
Handles all the safety, documentation, and approval work related to FSVP.
|
How Consultare Inc. Group supports you?
Consultare Inc. Group provides complete FSVP coverage, including:
✓ FSVP Agent (U.S. Representation)
✓ FSVP Qualified Individual (technical oversight and approvals)
✓ FSVP Importer of Record Service
✓ Hazard analysis, product review, supplier verification
✓ Shipment approval and documentation review
✓ Audit-ready FSVP files
We ensure you are fully compliant from supplier onboarding to shipment arrival .
We ensure you are fully compliant from supplier onboarding to shipment arrival .
Get Started: Contact us at info@consultareinc.com or submit your request via our online form.
Fees and Subscriptions
| Package | Fee (USD) | Inclusions | Action |
|---|---|---|---|
| One-time FSVP Agent Service - Per-Shipment Representation | $149 per shipment |
Designation as FSVP Agent for a single shipment under 21 CFR §1.509 Issuance of formal authorization/attestation letter confirming representation for the shipment Up to 1 hour of remote support for logistics, broker, or regulatory (FDA/USDA) compliance-related inquiries or coordinations specific to the shipment |
Subscribe |
| Basic FSVP Agent + Oversight | $749/year (or $75/month, with 1-year lock-in) |
All features in Basic package; plus: FDA/Regulatory communications log, if any Dedicated email support (up to 12 correspondences/email forwardings per year) during FDA inquiries or inspections Guidance and notifications on regulatory changes Compliance reminders (e.g., FDA registration renewal, inspection notice response, supplier reevaluations), if any Documentation review checklist for FSVPQI activities Digital FSVP Compliance Folder in InterlinkIQ (optional; if availed with software subscription) Up to total of 6 hours per year of standard remote coaching/support (i.e., inspection walkthrough, or remote guidance) per year for compliance-related inquiries, on top of email forwardings |
Subscribe (Annual) Subscribe (Monthly) |
| FSVP Agent Oversight + Comprehensive Inspection Support | Custom Quote |
Everything in Basic FSVP Agent + Oversight, plus: FSVPQI/US Agent designation information Annual review for FSVP procedures (with recommendations, if any) Documents Review Checklist for FSVP Activities Up to total of 20 email correspondences/email forwardings per year during FDA inquiries or inspections Up to total of 10 hours of standard remote coaching/support (i.e., strategy meetings, FDA response development, alignment discussions, or inspection walkthrough) per year for FDA or USDA-related inquiries, on top of email forwardings |
Subscribe |
| End-to-end FSVP Oversight | Custom Quote |
Everything in Basic FSVP Agent + Oversight, plus: Full FSVP Program and monitoring records development and customization (per 21 CFR 1.500–1.514 & 117 Subpart G) Remote FSVPQI activities, including initial/annual/quarterly supplier verification and FSVP implementation, reassessment, and updating, based on regulatory best practice Unlimited email forwarding for FDA/regulatory inquiries, inspection notices, complaints, records requests, or recalls Verification of shipment entry documents and Prior Notices Remote coaching and support for any regulatory notices, compliance-related inquiries, starting at 20 hours per month |
Subscribe |
Add-Ons:
- • Prior Notice Filing – $75 per product/shipment • FDA Food Facility Registration (initial) - $450 per facility • Product Label Compliance Review - starts at $750 per product • Additional remote support hours - Custom Quote • Expedited deliverable turnaround - Custom Quote
Ideal For:
- • Foreign suppliers of human food, dietary supplements, beverages, and ingredients
- • Exporters shipping to the U.S. without a U.S.-based importer or business entity
- • Contract manufacturers, brand exporters, or bulk processors selling into the U.S. market
Service Activation Timeline
- • 48 Hours or less upon receipt of completed onboarding form and payment
Regulatory References
- • 21 CFR 1.500–1.514 – Foreign Supplier Verification Program
- • 21 CFR 117 Subpart G – Supply Chain Program Requirements
- • 21 CFR 117.139 – Recall Plan Requirements
- • 21 CFR 1.509 – Import Entry Requirements
- • FDA Guidance for Industry: FSVP for Importers of Food for Humans and Animals
Note: Services are subject to Terms of Service.
