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FSVP Defined
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FSVP PLAN CREATION

OVERVIEW: Title 21 of the United States (U.S.) Code of Federal Regulations requires that all U.S.-based owners or consignees of imported food, beverage, or dietary supplement products develop, maintain, and follow a Foreign Supplier Verification Program (FSVP Plan) that provides adequate assurances that the foreign supplier is producing the product in compliance with processes and procedures that provide at least the same level of public health protection as those required under the Preventive Controls for Human Food, or Product Safety Rule.

 

As a property designated Qualified Individual (QI) firm, United Safety Agents can perform all verification activities on your  behalf and deliver complete, FDA-inspection ready FSVP Plans to keep you in full compliance with FSVP.

The following steps typically comprise the initial and ongoing FSVP verification process.

FDA FSVP Initial Consultation

STEP NO. 0NE   |   INITIAL CONSULTATION

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 complimentary consultation. Once booked, our team will we available to you – at length – to answer any questions that you may have and provide you with insight into your company’s regulatory standing. Schedule call

FDA FSVP Document Review

STEP NO. TWO   |   DOCUMENT REQUESTS

Based upon 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.  We typically initiate contact with each of your suppliers and directly acquire all necessary food safety documents - download list.

FDA FSVP Preliminary Review

STEP NO. THREE   |   PRELIMINARY REVIEW

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 receipt of all necessary documentation, or

B. request additional information and/or documents.

FDA FSVP Plan Creation

STEP NO. FOUR   |   FSVP PLAN CREATION

USA’s team of FDA and FSVP experts will leverage our 95+ years of 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; and other relevant implementing regulations. USA will document and deliver individual, product-specific FSVP plans for your review.

FDA FSVP Certificate

STEP NO. FIVE   |   CERTIFICATES ISSUED

Once your supplier(s) have successfully undergone the FSVP certificaion process, United Safety Agents will issue your company a Certificate of FSVP compliance. This Certificate is free for your dissemination and can serve as a helpful tool to substantiate your company's compliance with customers.

FDA FSVP Compliance Monitoring

STEP NO. SIX   |   COMPLIANCE MONITORING

21 CFR part 1, subpart L requires that all FSVP Plans 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.

FDA FSVP Services
FDA FSVP Audit

FDA FSVP AUDIT COVERAGE

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. 

FDA FSVP Learn More

LEARN MORE / SERVICE QUOTATION

USA' services are designed to provide our clients with customized FSVP compliance solutions and are tailored to your 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

To start the process or learn more about how FSVP applies to your business, complete and submit the following form and your results will be sent to you upon review.

Contact information will only be used to send results and follow up, if necessary.

Any information you provide will remain confidential.

 

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