Tag: HARPC

So it Begins: FSVP Inspections

FDA has begun inspecting U.S. food importers for their compliance with the Foreign Supplier Verification Program (FSVP). The FSVP regulation has a staggered compliance date between May 30, 2017 through July 27, 2020 (depending on the food type and the foreign supplier’s size). Those subject to that first compliance date may soon be inspected by FDA, if not already.

It is our understanding that these first inspections are part of an “educate while regulate” paradigm discussed by Sharon Mayl and others, during which FDA has their regulatory “hammer put away. Thus FDA is pre-announcing the inspections and spending additional time explaining the rules and the Agency’s expectations. While the hammer is away, importers must take these inspections seriously as first impressions are long lasting in that they set the tone with FDA.

We have been working closely with our clients to understand the regulation, establish a robust FSVP protocol, and counsel them on how to make a good lasting first impression. FDAImports.com is pleased to report that the FSVP plans we have helped clients put into place are receiving very favorable comments from FDA’s inspectors with only minor suggestions for improvements. When asked about this outcome John F. Johnson III, our lead FSVP authority replied, “one of many important keys to getting control of the inevitable FDA inspection is to not copy and paste the foreign food supplier’s hazard analysis and substantive preventative controls into the FSVP protocol. You must make the hazard analysis your own, and understand the preventive controls. This is to seek to prevent the inspection from turning into a proxy inspection of the foreign supplier and their technical application of HARPC (Preventive Control Rule), and not about your FSVP operations.”

For help setting up your FSVP and staying compliant with the FDA contact us today!