How to Comply with FDA’s Voluntary Qualified Importer Program?

  • By: Staff Editor
  • Date: February 06, 2017
  • Source:
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How to Comply with FDA’s Voluntary Qualified Importer Program?

FDA’s Voluntary Qualified Importer Program (VQIP), one of the key requirement of the Food Safety Modernization Act (FSMA), is aimed to expedite the reviewing and importing process of foods from certified facilities. In November 2016, FDA published its final guidance that details how the VQIP will work.

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The guidance document outlines expected benefits for VQIP importers, eligibility criteria, guidelines for completing a VQIP application and, the situations that may result in the revocation of involvement in VQIP. The topics addressed in this guidance are categorized into following sections:

  • Voluntary Qualified Importer Program Benefits
  • Importer
  • Eligibility
  • Foreign Supplier Facility Certification
  • VQIP Application
  • VQIP Quality Assurance Program
  • Application Period and VQIP Fiscal Year
  • FDA VQIP Application Review
  • VQIP Application Amendments
  • VQIP User Fees
  • Revocation of VQIP Participants
  • Reinstatement of VQIP Participants

Questions and Answers

This regulatory document provides the summary of guidelines in question and answer format. Some of the key questions addressed in this guidance include:

  • What are the benefits of VQIP participation?
  • What information should be submitted at entry to identify a VQIP food?
  • Under what circumstances will FDA examine or sample a VQIP food?
  • Who can participate in VQIP?
  • What are the eligibility criteria for participation in VQIP?
  • What is a facility certification?
  • What is a regulatory audit?
  • How to submit an application to participate in VQIP?
  • What information is needed to complete a VQIP application?
  • How is a DUNS number used in a VQIP application?
  • What is a VQIP Quality Assurance Program (QAP)?

This FDA guidance document has addressed these questions and many more to ensure clarity in adhering to VQIP requirements.

Click here to download the file
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