FDA Agent Pro Scope of Services and Terms and Conditions Service: FSVP Agent and Product Assessment Scope of Services
1. By completing this form, you agree that all the information provided in this form is accurate and truthful.2. The completion of the form does not denote the completion of the supplier verification process. You must not use our nameas an FSVP agent until the FSVP agreement is signed.3. We may ask for additional information during our document review process.4. This form should be filled out by the facility's owner/operator or person in charge; if you are filling out the form on behalf ofthe manufacturer, you confirm that you have written authorization from the facility's owner/management.5. Other terms of services mentioned on our website shall apply.6. I agree to assume all risk, release FDA Agent Pro LLC's officers, directors, employees, affiliates,and agents from any and all liability in connection with the product and its listing, waive all claims, and hold harmless andindemnify FDA Agent Pro LLC and its officers, directors, employees, affiliates, and agents from anyand all claims in connection with this product, its marketing, labeling, or listing with the FDA.7. Providing incorrect or incomplete information may delay the supplier verification.
SERVICES AGREEMENT
This agreement is between the FDA Agent Pro LLC, a California corporation, and You, a client.
WHEREAS, You desire FDA AGENT PRO LLC to serve as U.S.-based Foreign Supplier Verification Program (FSVP) agent for 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling. You are required to register with the U.S. Food and Drug Administration (FDA) in accordance with section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Food Safety Modernization Act, and FDA regulations under Title 21 Code of Federal Regulations (C.F.R.), Part 1, Subpart H;
WHEREAS, FDA AGENT PRO LLC desires to act as a U.S.-based FSVP agent for your food facilities, as defined below.
NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants and agreements set forth, the parties agree as follows:
Deliverables: Customized FSVP plan, verification reports, compliance certificates, and record archive. Timeline: Onboarding in 1-2 weeks; initial verifications in 4-6 weeks; ongoing as needed.
Assumptions: Client provides accurate information promptly; we assume no liability for supplier fraud or client-provided data inaccuracies.
This service ensures proactive compliance, minimizing import delays and risks.
1. Scope of Services: Foreign Supplier Verification Program (FSVP) ComplianceFDA Agent Pro will provide comprehensive FSVP services to ensure your imported food products comply with FDA regulations under the Food Safety Modernization Act (FSMA). As your designated U.S.-based FSVP agent/importer, we will handle the following on your behalf:• Initial Assessment and Planning: Review your imported products and suppliers to determine FSVP applicability, conduct hazard analyses (identifying biological, chemical, and physical risks), and develop a customized written FSVP plan.• Supplier Evaluation and Verification: Evaluate foreign suppliers' food safety performance, including review of their plans and history. Perform required verification activities such as onsite audits, product sampling/testing, record reviews, or other FDA-approved methods, with frequency based on risk (e.g., annual for high-risk items).• Corrective Actions and Monitoring: Address any non-compliances through corrective measures, supplier notifications, and import holds if needed. Conduct ongoing monitoring and reevaluations (at least every three years or as risks change).• Record-Keeping and Reporting: Maintain all required FSVP records (e.g., analyses, verification results, corrective actions) for the mandated period. Provide you with periodic compliance reports and access to records.• Import Entry Support: Act as the identified FSVP importer for CBP entries, providing our name, email, and DUNS number. Respond to FDA record requests within 24 hours.• Training and Guidance: Advise your team on FSVP best practices and provide documentation for your internal training.
2. Limitation of Services: This scope does not include legal representation, product recalls, or non-FSVP compliance (e.g., labeling, facility registration). Any additional services (e.g., extra audits) will be quoted separately. FDA AGENT PRO LLC is not the U.S. agent for your facilities per 21 CFR § 207.69(b).
3. FDA AGENT PRO LLC Is Not Your Agent-in-Charge: It is expressly understood and agreed that FDA AGENT PRO LLC is not your agent-in-charge. Accordingly, You retain all responsibility for ensuring that your facilities are registered with FDA in accordance with the FDCA and regulations promulgated thereunder, and for complying with all other applicable requirements under U.S. law including, but not limited to, any requirement to provide information about your facilities or products to FDA or take any specific action with respect to your facilities or products.
4. Facility Contact Information: Immediately upon entering into this Agreement, You shall provide FDA AGENT PRO LLC with full and accurate contact information for each and every facility for which FDA AGENT PRO LLC will serve as U.S. agent under this Agreement. If You have multiple facilities, you must submit the Facility Information Form found at Appendix B for each facility for which You have designated FDA AGENT PRO LLC as Your U.S. Agent. You shall notify FDA AGENT PRO LLC immediately of any change or modification to this contact information at the email address provided in Section 7 of this Agreement. Failure to apprise FDA AGENT PRO LLC in a timely manner of such changes or modifications shall render this Agreement null and void.
5. Term: This Agreement shall commence immediately upon the receipt of this fully executed Agreement and payment of your annual FDA AGENT PRO LLC renewal fee for FSVP Services. This Agreement will renew automatically for successive terms of one year unless terminated pursuant to the terms hereof.
6. Termination: Either party may terminate this Agreement at any time and without cause upon written notice to the other party, which must be provided no less than 60 days prior to such termination. The written notice shall specify the effective date of termination.
7. FDA AGENT PRO LLC Contact Information: All correspondences related to this Agreement should be directed to the following email address: info@fdaagentpro.com.
8. Indemnity: You shall indemnify and hold harmless FDA AGENT PRO LLC, its officers, directors, employees, servants, agents, affiliates, and members from and against any and all claims, demands, costs, damages, liabilities, losses, actions, assessments, charges, and expenses (including, without limitation, interest, FDA reinspection fees, penalties, and attorneys’ fees and disbursements) which may at any time be suffered or incurred by, or be asserted against, any one or more of them, directly or indirectly, on account of or in connection with this Agreement, except where such claim is based on the gross negligence or willful misconduct of FDA AGENT PRO LLC in satisfying its obligations under this Agreement.
9. Assignment: No party shall assign this Agreement without the prior written consent of the other party. Any purported assignment without prior written consent shall be null and void and have no force or effect.
10. Governing Text: All disagreements, disputes, and claims of any kind under this Agreement, including any litigation or arbitration of purported claims, shall be governed by and be construed under the English language text of this Agreement.
11. Governing Law: This Agreement shall be governed by, and construed in accordance with, the laws of the State of California without regard to principles or conflicts of law.
12. Entire Agreement: This Agreement, including the Appendices hereto, contains the entire agreement between the parties with respect to the subject matter hereof and supersedes any and all prior oral or written agreements, commitments, or understandings. No amendment or modification of this Agreement shall be valid or binding unless set forth in writing and duly executed by both parties.
This agreement is between the FDA Agent Pro LLC, a California corporation, and You, a client.
WHEREAS, You desire FDA AGENT PRO LLC to serve as U.S.-based Foreign Supplier Verification Program (FSVP) agent for 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling. You are required to register with the U.S. Food and Drug Administration (FDA) in accordance with section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Food Safety Modernization Act, and FDA regulations under Title 21 Code of Federal Regulations (C.F.R.), Part 1, Subpart H;
WHEREAS, FDA AGENT PRO LLC desires to act as a U.S.-based FSVP agent for your food facilities, as defined below.
NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants and agreements set forth, the parties agree as follows:
Deliverables: Customized FSVP plan, verification reports, compliance certificates, and record archive. Timeline: Onboarding in 1-2 weeks; initial verifications in 4-6 weeks; ongoing as needed.
Assumptions: Client provides accurate information promptly; we assume no liability for supplier fraud or client-provided data inaccuracies.
This service ensures proactive compliance, minimizing import delays and risks.
1. Scope of Services: Foreign Supplier Verification Program (FSVP) ComplianceFDA Agent Pro will provide comprehensive FSVP services to ensure your imported food products comply with FDA regulations under the Food Safety Modernization Act (FSMA). As your designated U.S.-based FSVP agent/importer, we will handle the following on your behalf:• Initial Assessment and Planning: Review your imported products and suppliers to determine FSVP applicability, conduct hazard analyses (identifying biological, chemical, and physical risks), and develop a customized written FSVP plan.• Supplier Evaluation and Verification: Evaluate foreign suppliers' food safety performance, including review of their plans and history. Perform required verification activities such as onsite audits, product sampling/testing, record reviews, or other FDA-approved methods, with frequency based on risk (e.g., annual for high-risk items).• Corrective Actions and Monitoring: Address any non-compliances through corrective measures, supplier notifications, and import holds if needed. Conduct ongoing monitoring and reevaluations (at least every three years or as risks change).• Record-Keeping and Reporting: Maintain all required FSVP records (e.g., analyses, verification results, corrective actions) for the mandated period. Provide you with periodic compliance reports and access to records.• Import Entry Support: Act as the identified FSVP importer for CBP entries, providing our name, email, and DUNS number. Respond to FDA record requests within 24 hours.• Training and Guidance: Advise your team on FSVP best practices and provide documentation for your internal training.
2. Limitation of Services: This scope does not include legal representation, product recalls, or non-FSVP compliance (e.g., labeling, facility registration). Any additional services (e.g., extra audits) will be quoted separately. FDA AGENT PRO LLC is not the U.S. agent for your facilities per 21 CFR § 207.69(b).
3. FDA AGENT PRO LLC Is Not Your Agent-in-Charge: It is expressly understood and agreed that FDA AGENT PRO LLC is not your agent-in-charge. Accordingly, You retain all responsibility for ensuring that your facilities are registered with FDA in accordance with the FDCA and regulations promulgated thereunder, and for complying with all other applicable requirements under U.S. law including, but not limited to, any requirement to provide information about your facilities or products to FDA or take any specific action with respect to your facilities or products.
4. Facility Contact Information: Immediately upon entering into this Agreement, You shall provide FDA AGENT PRO LLC with full and accurate contact information for each and every facility for which FDA AGENT PRO LLC will serve as U.S. agent under this Agreement. If You have multiple facilities, you must submit the Facility Information Form found at Appendix B for each facility for which You have designated FDA AGENT PRO LLC as Your U.S. Agent. You shall notify FDA AGENT PRO LLC immediately of any change or modification to this contact information at the email address provided in Section 7 of this Agreement. Failure to apprise FDA AGENT PRO LLC in a timely manner of such changes or modifications shall render this Agreement null and void.
5. Term: This Agreement shall commence immediately upon the receipt of this fully executed Agreement and payment of your annual FDA AGENT PRO LLC renewal fee for FSVP Services. This Agreement will renew automatically for successive terms of one year unless terminated pursuant to the terms hereof.
6. Termination: Either party may terminate this Agreement at any time and without cause upon written notice to the other party, which must be provided no less than 60 days prior to such termination. The written notice shall specify the effective date of termination.
7. FDA AGENT PRO LLC Contact Information: All correspondences related to this Agreement should be directed to the following email address: info@fdaagentpro.com.
8. Indemnity: You shall indemnify and hold harmless FDA AGENT PRO LLC, its officers, directors, employees, servants, agents, affiliates, and members from and against any and all claims, demands, costs, damages, liabilities, losses, actions, assessments, charges, and expenses (including, without limitation, interest, FDA reinspection fees, penalties, and attorneys’ fees and disbursements) which may at any time be suffered or incurred by, or be asserted against, any one or more of them, directly or indirectly, on account of or in connection with this Agreement, except where such claim is based on the gross negligence or willful misconduct of FDA AGENT PRO LLC in satisfying its obligations under this Agreement.
9. Assignment: No party shall assign this Agreement without the prior written consent of the other party. Any purported assignment without prior written consent shall be null and void and have no force or effect.
10. Governing Text: All disagreements, disputes, and claims of any kind under this Agreement, including any litigation or arbitration of purported claims, shall be governed by and be construed under the English language text of this Agreement.
11. Governing Law: This Agreement shall be governed by, and construed in accordance with, the laws of the State of California without regard to principles or conflicts of law.
12. Entire Agreement: This Agreement, including the Appendices hereto, contains the entire agreement between the parties with respect to the subject matter hereof and supersedes any and all prior oral or written agreements, commitments, or understandings. No amendment or modification of this Agreement shall be valid or binding unless set forth in writing and duly executed by both parties.