FSVP/QI/US Agent Services Q & A

Q: What is the FSVP/QI/US Agent Services Agreement?

A: The FSVP/QI/US Agent Services Agreement is a contract between Consultare Inc. Group (the Agent) and a foreign entity, appointing the Agent as the exclusive representative for compliance and regulatory support in the U.S. This includes handling communication, compliance, and documentation related to food safety and import requirements.

What services are included in the FSVP/QI/US Agent Services?

A: • The services provided include:

  • Communication Facilitation: Managing interactions during recalls or food safety events and acting as a liaison with U.S. stakeholders.
  • Regulatory Liaison: Engaging with U.S. regulatory bodies like the FDA, USDA, and FTC.
  • Compliance Support: Offering guidance on U.S. food safety laws, reviewing FSVP Programs, and assessing supplier compliance.
  • Documentation and Reporting: Preparing regulatory reports and maintaining compliance records.
  • Additional Services: Providing any other mutually agreed-upon services.

Q: How does the Agent facilitate communication during a recall or food safety event?

A: The Agent handles all communication with U.S. customers, partners, and regulatory bodies, ensuring timely and accurate information flow to manage and mitigate the situation effectively.

Q: Which U.S. regulatory authorities does the Agent liaise with?

A: The Agent interacts with key U.S. regulatory authorities, including the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Federal Trade Commission (FTC).

Q: What is included in the FSVP Program review?

A: The FSVP Program review includes evaluating the Foreign Entity’s written FSVP Program for compliance with FDA regulations, such as Preventive Controls for Human Food and Animal Food, Produce Safety, Dietary Supplement CGMPs, Adulteration, and Allergen Labeling.

Q: How does the Agent support compliance with U.S. food safety laws?

A: The Agent provides expert guidance on U.S. food safety laws and import requirements, helping the Foreign Entity understand and meet regulatory obligations.

Q: What additional services can be provided beyond the standard agreement?

A: Additional services can be offered based on a mutual written agreement between the Agent and the Foreign Entity. These services will be tailored to meet specific needs not covered in the standard scope.tive financial management and planning.

If you have any more questions or need further clarification, feel free to reach out to us!

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