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Terms of Service

Effective Date: January 1, 2025

Operated by: FSVPServices.com, a service platform of Consultare Inc. Group, A Compliance Company (“Company”)

Please read these Terms of Service ("Terms") carefully before using the services provided by FSVPServices.com. By accessing or using our website, services, or engaging with us as a client, you (the “Client”) agree to be bound by these Terms.

1. Scope of Services

FSVPServices.com provides compliance support services including, but not limited to:

• Foreign Supplier Verification Program (FSVP) Agent and Qualified Individual (FSVPQI) services
• U.S. FDA U.S. Agent representation
• Importer of Record (IOR) representation and administrative facilitation
• FDA registration assistance
• Compliance documentation management
• Regulatory training and consulting
• Preventive Controls Qualified Individual (PCQI) support
• Regulatory review of product labeling and documentation
• Facilitation of submissions to FDA, USDA, or other U.S. regulatory agencies

All services are rendered under the management and direction of Consultare Inc. Group, A Compliance Company.

2. Eligibility

By engaging the Company’s services, the client affirms that they:

• Are at least 18 years old or of legal age to enter into a binding agreement
• Are authorized to act on behalf of the business entity they represent

3. Client Responsibilities

The client agrees to:

• Provide accurate, timely, and complete business, supplier, and product information
• Cooperate in providing required documentation, records, and declarations necessary for compliance with the regulatory authorities (e.g, USDA, FDA, CBP, FTC)
• Inform FSVPServices.com of any regulatory updates, inspections, or enforcement actions related to their company or products
• Maintain active and timely communication with FSVPServices.com to help facilitate the duly diligent execution of services
• Acknowledge that ultimate compliance responsibility lies with the Client and/or their suppliers, unless stated otherwise.

4. Fees and Payment

4.1 Pricing for Services
Pricing for services are detailed on each respective Services page or as agreed upon in a separate service proposal. All payments are:
• Due in full prior to service activation unless otherwise agreed;
• Non-refundable once services have commenced;
• Subject to late fees, where necessary; and
• Subject to grounds for suspension or termination of services if unpaid, with the Company assuming the absolute right to evaluate thereof
4.2 Rollover Policy
For clients engaged under monthly retainer agreements, any unused service hours or credits may be rolled over for a maximum period of three (3) consecutive months from the date of accrual. After this period, any remaining unused balance shall be forfeited and will not be credited, refunded, or carried forward further.

5. Service-Specific Terms

5.1 U.S. Agent and FSVP Agent Role

• The Company’s designation as FDA U.S. Agent or FSVP Agent is strictly representational.
• This role does not make the Company responsible for product quality, labeling, or manufacturing practices.
• The Client remains solely responsible for corrective actions, supply chain oversight, process documentation, records management, risk assessments, verification activities, and compliance with the applicable regulations.

5.2 Importer of Record (IOR) Representation

• The Company acts as Importer of Record (IOR) strictly for regulatory filing purposes, and is limited to representation and administrative support. The Client remains the legal owner and responsible party for all imported goods, including any related fees that may arise from import clearance proceedings (such as FDA/Customs/legal fees, tariffs, bonds, taxes, or duties).
• The Company shall not be responsible for freight forwarding, product storage, warehousing, distribution, transportation, customs brokerage or filings, or logistics.
• The Client indemnifies the Company from liability arising from shipment detentions, refusals, recalls, or destruction resulting from any form of non-compliance, including those caused by incomplete, inaccurate, or delayed documentation provided by the Client.

5.3 FSVP Qualified Individual (FSVPQI) Services

• If designated as FSVPQI, the Company may provide oversight and review of supplier verification activities, and/or develop and implement the verifications thereof, per FDA requirements.
• This role does not absolve the Client of responsibilities to provide accurate supplier information and records and maintain compliance.
• By designating FSVPServices.com to appoint a Qualified Individual (QI) to support FSVP compliance, the Client agrees to provide accurate records or disclosures which the Company will utilize in its execution of the service scope with due diligence.

5.4 Preventive Controls Qualified Individual (PCQI) Services

• PCQI services may include training, consultancy, verification activities, food safety plan development and/or review, preventive control oversight, and document preparation support, where applicable per contract signed prior to the execution of the selected services.
• The Client retains full responsibility for implementing the developed procedures, training materials, and records within their facility or supply chain.

5.5 Regulatory Reviews

• Regulatory reviews are conducted based on documents, labels, or records submitted by the Client.
• The Company does not independently verify the accuracy of supplier testing, labeling claims, or certifications.
• For any document requests, the Client shall provide within ten (10) business days, unless otherwise stated in a written contract, from the date the initial request was issued for such document. Any record/s not submitted within this window shall be deemed deficient, and the Company shall proceed with the review commencement based only on the documentation received.
• For services that cover the assessment of a limited number of revisions, clients must submit the revision/s within ten (10) business days, unless otherwise indicated in the contract, from the date the Compliance Assessment Report is issued. Reviews that remain inactive beyond this period will be considered closed, and may be subject to reopening fees.
• Recommendations are advisory and do not guarantee regulatory acceptance or clearance.

5.6 Regulatory Submissions

• When facilitating regulatory submissions (e.g., FDA Prior Notice, FDA Food Facility Registrations, USDA Import Permits, CBP filings through licensed brokers), the Company’s actions are limited to administrative capacity and facilitation support, which are executed to align with regulatory submission guidelines.
• Submission accuracy depends on complete and accurate information provided by the Client.
• Regulatory outcomes, approvals, or exemptions cannot be guaranteed.

6. Confidentiality

The Company maintains strict confidentiality of all proprietary and business-sensitive information provided by the Client, except:

• As required by law, regulatory inquiry, or third-party auditors
• With the client’s consent or approval
• As part of collaborative compliance management within Consultare Inc. Group, its authorized personnel

7. Intellectual Property

All materials, templates, training content, and documentation provided by the Company are the intellectual property of Consultare Inc. Group and may not be reproduced, shared, or resold without written consent.

8. Disclaimers

By agreeing to have Consultare Inc. Group execute the selected services, the Client acknowledges that:
• The Company is not a law firm and does not provide legal advice.
• Consultancy and compliance support services are provided on a best-effort basis according to current regulatory guidelines and client-provided information.
• The Company does not guarantee regulatory approval, certification, clearance, or exemption.
• Engagement as IOR, FSVPQI, PCQI, FSVP Agent, or U.S. Agent does not transfer ownership, liability, or responsibility for any of the client’s products, services, or compliance standing.

9. Termination

The Client acknowledges that:

• In the event of non-payment, all service engagements will cease.
• Either party may terminate service with written notice at least thirty (30) days prior to the intended date of effectivity.
• Any outstanding balances are not refundable under any circumstances, including but not limited to the termination of any service agreements for any conceivable cause.

10. Limitation of Liability

By availing any of the services, FSVPServices.com and Consultare Inc. Group, as well as its officers and employees, shall not be liable for any and all claims, actions, penalties, damages, liabilities, costs, loss of revenue, profits, or data, and expenses (including reasonable attorney’s fees) arising out of or relating to:

• The client’s products;
• Regulatory enforcement actions resulting from false, incomplete, or delayed client submissions;
• The client’s failure to provide complete and accurate information;
• Third-party acts, including customs brokers, freight forwarders, carriers, or regulators

11. Indemnification

The Client agrees to indemnify, defend, and hold harmless Consultare Inc. Group, including FSVPServices.com, its officers, employees, and affiliates from and against any and all claims, damages, losses, liabilities, costs, or expenses (including reasonable attorney’s fees) arising out of or relating to:

• The Client’s products;
• The Client’s failure to comply with U.S. regulations;
• False, incomplete, or delayed submissions provided by the Client;
• Third-party acts, including customs brokers, freight forwarders, carriers, or regulators

12. Governing Law

These Terms shall be governed by and construed in accordance with the laws of the State of Texas, United States, without regard to conflict of laws principles.

13. Amendments

The Company reserves the right to update these Terms and post any updates on this page at any time. Such updates shall apply to all existing and future contracts. The Client’s continued engagement with the Company, including but not limited to the facilitation of any payment, or submission of any signed service agreements, shall constitute acceptance of the updated Terms.

14. Contact Information

For questions, concerns, or legal correspondence regarding these Terms:

  • Email: info@consultareinc.com
  • Consultare Inc. Group – Compliance Division