UPDATE 03/29/2018: FDA has committed to well over 1,000 FSVP inspections this year, so the likelihood one will be at your office has increased significantly.
The reach of the Food Safety Modernization Act (FSMA) is slowly being seen in FDA enforcement activities. Recently, FDA published a list of the inspection violations encountered during fiscal year 2017. While the most common violations focused on lack of measures for controlling pests and for specific sanitizing operations, an important violation was the failure to develop a Foreign Supplier Verification Program (FSVP).
The FSVP rule, issued as a part of FSMA, had its first compliance date on May 30th of last year. The FSVP rule requires that importers of food products develop a verification program demonstrating that their suppliers have adequately controlled for any chemical, physical, and microbiological hazards that occur during production and processing.
FDA wants a plan in place for each food.
Back in May 2017, we published a blog predicting that upcoming FDA inspections would begin to focus on FSVP plans, most likely centered on whether the importer has an FSVP plan for each food rather than on deep audits into the FSVP plans themselves. Since FDA had not issued any specific guidance on FSVP plans, we imagined it would be difficult to enforce specific requirements. Indeed, our prediction was correct; out of 177 FSVP documentation violations in fiscal year 2017, 111 were for simply not having an FSVP plan for a product.
The FSVP plan requirements are not the only FSMA rules being enforced. In fiscal year 2017, FDA cited 531 violations of FSMA requirements found in 21 CFR 117, out of a total 2662 food violations. When you compare that to the ten 21 CFR 117 violations cited in fiscal year 2016 (out of 2196 total violations), then the impact FSMA is making on inspectional violations is clear.
The FSMA is slowly creeping into FDA enforcement activities. The next critical compliance date is March 19, 2018. Therefore, having an adequate and compliant FSVP program is even more important this year, as the chances of an FDA FSVP inspection will increase substantially beginning early April 2018. Learn more about our FSVP compliance services and cloud-based software at FDAiVerify.com
