November 28, 2016

Patrick Kennedy, Mérieux NutriSciences USA

USA: FDA issues Final Guidance for Voluntary FSMA Program for Food Importers

VQIP is scheduled to launch in January 2018
Mérieux NutriSciences VQIP

On November 10, FDA released its final guidance for industry regarding the Voluntary Qualified Importer Program (VQIP).  Described as the “fast lane” system for facilitating the entry of imported food shipments into the United States, the VQIP program would provide benefits such as expedited review and limited FDA examination and/or sampling of food imports.

Importers seeking to join the program must have at least a 3-year history of importing food into the U.S. without an Import Alert or Class 1 recall associated with any imported food.   Moreover, importers cannot be subject to an ongoing FDA administrative or judicial action (e.g. Import Alert, injunction and debarment) or any noncompliance related to food safety. 
Supplier verification is an important component of VQIP. Eligible importers must have a current facility inspection conducted for each foreign supplier of food imported under the program.   

Foreign suppliers must obtain certification from third-party certification bodies accredited by the FDA to establish eligibility to participate in the program.   A regulatory audit must be conducted to obtain certification under VQIP.
Certification bodies will be required to submit regulatory audit reports directly to their accreditation body and FDA. If an entity must implement corrective actions due to the findings of a regulatory audit, the certification body cannot issue a food or facility certification until the facility has submitted its corrective action plans.  The certification body must verify the plan addresses the deficiencies and corrective actions are properly implemented.

Under VQIP, FDA will limit examination and/or sampling of VQIP food entries to ‘for cause’ situations, but the agency predicts these situations would be rare.  The FDA draft guidance indicated the agency would expedite laboratory analysis of ‘for cause’ or audit samples from VQIP suppliers. The agency published three documents to facilitate industry compliance with the VQIP program, including the final guidance for VQIP in a question-and-answer format, a fact sheet on the final guidance, and instructions for submission of a VQIP application.
VQIP is scheduled to launch in January 2018.

Source:U.S. Food and Drug Administration 

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