FDA/FSVP – AGENT Services
Groupe Transit is a highly qualified, FSVP-designated Agent and Importer firm that offers an array of services to partner manufacturers, processors, exporters, and logistics companies. From establishing compliance requirements for the Foreign Supplier Verification Program (FSVP) to providing dedicated Agency coverage – Groupe Transit’s range of expertise has you covered every step of the way.
– Manufacturing / Food
– First Registration
– Annual Renewal Registration
Our Services include:
– Scheduling an initial call to strategize and plan your FSVP application.
– Assessing and validating your quality control program for the FSVP program certification.
– Qualifying your quality control manager for the FSVP program.
– Providing you with an FSVP certificate of compliance upon successful verification
How Groupe Transit will Help you Navigate FSVP
Step One | Initial Conversation
FSVP is complex and contains many modifications and exemptions. It is important that we first learn about your company, the ingredients of your products, and its specific needs. We have to evaluate the level of contamination risk of the ingredients. So, at the beginning of the process we need to talk with you to learn how FSVP applies to your operation. Once booked, our team will be made available – at length – to answer any questions that you may have and provide you with insight into your company’s regulatory standing.
Step Two | Food Safety Documents
Following our discussion, to ensure that all potential risks are being managed in a manner consistent with the FDA’s domestic regulations (Preventive Controls Rule or Produce Safety Rule) and to maintain the same level of public health protection, we will require documentation of the processes, procedures, and control methods employed by each manufacturer. In the event that you are not the manufacturer of the product, we can reach out to your suppliers on your behalf and collect all the essential food safety documents directly.
Step Three | Regulatory Assessment
After we have received all the required documents, we will conduct an initial assessment. However, since your facility is distinct from others in the same product category, and each product has its unique set of inherent hazards, as well as a limitless range of processing techniques, the specific food safety documents required for compliance will vary from one manufacturer to the next.
Based on the results of this preliminary evaluation, we will either:
– Verify that we have received all the essential documentation, or
– Request supplementary information and/or documents if necessary.
Step Four | FSVP Certification
Our team of FDA/FSVP professionals at Groupe Transit will utilize our extensive expertise in food safety and regulations to conduct a comprehensive assessment and validation of every product, as mandated by section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a), and the FSVP regulation in 21 CFR part 1, subpart L, or any other applicable regulations.
Moreover, Groupe Transit will serve as your representative in the event of an FDA inspection.
Step Five | Confirmation of FSVP Agent Coverage
Upon successful verification, Groupe Transit will provide a signed certificate confirming our acceptance of your company’s FSVP Agency program. This certificate can be presented by your customs broker or filer while clearing the entry of pre-approved products through U.S. Customs.
As a duly authorized and certified FSVP agent, Groupe Transit assumes the responsibility of serving as the point of contact for all FSVP-related interactions with the FDA. In the event that the FDA initiates an FSVP inspection, Groupe Transit will arrange for an in-person or virtual conference with the FDA representative to review all the FSVP plans. Our clients have been subject to routine inspections, and we have consistently earned an A-1 rating for compliance. Due to our rigorous record-keeping practices, the FDA prefers to collaborate with Groupe Transit.