FDA/FSVP – AGENT Services

Get Started with your FSVP Application
Groupe Transit
Official FSVP Importer Firm/Agent Service for FDA Inspect
1-888-908-7267
[email protected]

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.

Requirements:
– 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

With Transit, we found a dedicated partner, eager to satisfy its customers, who has supported us more than once during our exports to the USA. Without them, we would have been quite lost during our first contacts with our neighbors to the south. They are always ready to help and can find solutions to our challenges. Validation of customs compliance, offer of an FSVP Importer, negotiation with the USDA and our broker during problems with customs, storage services respecting food standards, these are just a few of the services offered under one roof by the professional team at Transit. Transit facilitated our integration into the USA and we are very grateful.

ACTIV Foods Inc. www.happyyak.ca

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.

We are immensely satisfied with the services received by your team at Groupe Transit. From label verification to customs compliance validation, everything was perfect. You also solved the problems we had with the FDA and the USDA, which is no small feat 🙂 Thanks to your advice and knowledge, we even found an FSVP import, which allowed us to export our food to the United States. In addition, we had the opportunity to use your road transport services and once again we were delighted with the service and the very competitive prices. A thousand times thank you and best wishes for continued success, you all deserve it!

Moz www.mozpet.com

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.

We have been working with Groupe Transit for several years now and are very satisfied with their services. We are very grateful for all your work, whether for transport, customs clearance, tracking our shipments, and others, you are present, dedicated and trustworthy.

Aliments Tristan www.alimentstristan.com

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.