OVERVIEW OF PLAN CREATION SERVICE
The FDA's Foreign Supplier Verification Program (FSVP) is fundamentally concerned with food safety. As your company’s Qualified Individual, United Safety Agents' FDA-mandated goal will be to verify that an imported product’s inherent physical, chemical and biological hazards are being controlled in a manner at least equivalent to the FDA's domestic standards (Preventive Controls Rule or Produce Safety Rule). To accomplish this goal, our team of experts will undertake the followings steps on your company’s behalf:
STEP 01) Letter of Engagement.
Should your company choose to enlist USA to act as its Qualified Individual, USA will issue your company a signed Letter of Engagement. This Letter will formally transfer the responsibility of your company’s FSVP compliance program to USA and direct all FDA-related inquiries to our office.
STEP 02) Fact Finding & Document Acquisition.
USA will initiate contact with each of your company’s foreign suppliers via email. Our message will provide a brief explanation of the regulation, substantiate USA's engagement, and direct each supplier to visit USA's online "Client Upload Portal." Once logged in, the recipient will have access to a more thorough description of the requirements and a method to directly (and securely) submit all requisite food safety documents to USA. Please note: USA’s initial request is best received if proceeded by an introductory email sent from the importing customer (you). We have found that most suppliers are receptive to USA’s initial request and process their submission within the first several days. Please Note: Fact Finding & Document Acquisition service is optional. Participation will incur a separate charge billed at USA’s compliance consulting rate.
STEP 03) Preliminary Review & Additional Requests.
Once the requested documents have been received, a preliminary review will be performed. Depending on the outcome of this review, USA will either confirm that it has received all necessary documentation or respectfully request additional information and/or documents. 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 its FSVP will inevitably differ from one supplier to the next. Nonetheless, USA will continue to correspond with each supplier until sufficient information and documentation are obtained.
STEP 04) FSVP Verification & Plan Creation.
USA’s team of food safety/FSVP experts will leverage our 95 years of combined food safety and FDA 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 Foreign Supplier Verification Program regulation in 21 CFR part 1, subpart L.
On average, this verification process takes between fifteen and twenty-five man hours to complete. Once verified, USA will document and deliver our review via an individual, product-specific FSVP plan. Generally speaking, the process can be accomplished within 10-12 business days once USA has received all the necessary food safety documentation.
STEP 05) Delivery of Completed FSVP Plans.
For your convenience and to help manage the large about of information; a dedicated, user-friendly and password protected section of USA’s website will be utilized to facilitate the transfer and management of all completed FSVPs.
STEP 06) Maintenance & Continual FSVP Upkeep.
21 CFR part 1, subpart L requires that all FSVPs be updated and maintained over time. USA will re-verify each of your company’s products/suppliers on an annual and rolling basis. We will also ensure that all substantiating documents are kept up to date by continuously communicating with your company’s suppliers and their factories. All updates will be documented and reflected in your company’s FSVPs.
ANTICIPATED NEXT STEPS. Should you choose to engage USA as your company’s Qualified Individual, USA’s standard FSVP compliance program agreement will be forwarded for review. If the terms are found to be acceptable, USA will issue your company a signed Letter of Engagement and undertake all steps noted above.
FDA AUDIT REPRESENTATION. As your company’s Qualified Individual, it will be USA's responsibility to interface with the FDA on your behalf for all future FSVP-related audits. Our Agents will respond to any FDA inquiries and meet with the FDA's representative in-person or (via a remote arrangement) to review your company’s FSVP program(s).
FSVP PLAN CREATION PRICING. Because every company’s needs are different, more information will be required before an accurate quotation can be drafted. Please complete a brief questionnaire and a custom prospectus will be delivered within twenty-four hours.
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.