FDA FSVP AGENT/IMPORTER
As a properly designated and qualified FSVP Importer, United Safety Agents represents a diverse group of manufacturers, exporters, and logistics providers as their FSVP Importer and Agent. The following steps are typical when establishing FSVP compliance and Importer coverage.
Step One | Initial Conversation
FSVP is complex and contains many modifications and exemptions. It is important that we first learn about your company, its goals, and its specific needs. To begin the process and learn how FSVP applies to your operation, we invite you to schedule a phone call/meeting. 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
Based on our conversation, and to verify that all inherent hazards are being controlled in a manner that provides the same level of public health protection as the FDA’s domestic standards (Preventive Controls Rule or Produce Safety Rule), documentation of each manufacturer’s processes, procedures, and control methods will then be requested. If you are not the product's manufacturer, we can initiate contact with each of your suppliers and directly acquire all necessary food safety documents - download list.
Step Three | Regulatory Assessment
Once all requested documents have been received, a preliminary review will be performed. Since every product is different, has its own set of inherent hazards, and can be processed in one of an endless amount of ways – the specific food safety documents that will ultimately serve as a basis for compliance will differ from one manufacturer to the next. Depending on the outcome of this review, USA will either:
A) confirm that we have received all necessary documentation, or
B) respectfully request additional information and/or documents.
Note: Establishing FSVP Agency coverage can be expedited.
Step Four | FSVP Certification
USA’s team of FDA and FSVP experts will leverage our combined food safety and regulatory experience to thoroughly evaluate and verify each product as required under 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 other relevant regulations. USA will then document and retain our review via individual, product-specific FSVP Plans.
Step Five | Confirmation of FSVP Agent Coverage
Once verified, USA will issue an executed Letter of Consent. This Letter will confirm USA’s acceptance of your company’s FSVP Agency program and contain USA's DUNS Number, along with all other information necessary to clear the FSVP portion of U.S. Customs. This Letter and its contents will then be used by your Customs broker or filer when processing entry of previously approved products through U.S. Customs.
Step Six | FDA Compliance Monitoring
FSVP requires that all records be updated and maintained over time. USA ensures that there will not be an FSVP-related issue during the entry process for any of your products by continually updating and re-verifying each product and manufacturer on a rolling basis. Monitoring includes, but is not limited to: FDA Import Alerts, Warning Letters, Facility Inspections, Recall Events, and Document Updates.
FDA FSVP Inspection Assistance
As a properly designated and qualified FSVP Agent, it is USA's responsibility to interface with the FDA for all FSVP-related matters. Should the FDA trigger an FSVP inspection, USA will meet with the FDA representative in-person – or via a remote arrangement – to review all FSVP Plans. USA has undergone many FDA FSVP inspections and all FSVP Plans have exceeded FDA regulatory standards, every time.
Learn More / Service Quotation
USA' services are designed to provide our clients with customized FSVP compliance solutions and are tailored to their specific needs. Likewise, service rates can vary and are dependent upon the relative liability, complexity, and the level of each supplier’s food safety sophistication. To receive an accurate quotation, complete the Quotation Request form.
