FSMA Fridays: Third-Party Auditing (Part Four Of Four)

Check out the entire webcast or read part one, part two, and part three of this series

In part three of FSMA Fridays: Third-Party Auditing, SafetyChain Software’s VP of Marketing, Jill Bender was joined by The Acheson Group’s (TAG) founder and CEO Dr. David Acheson to discuss FSMA's third-party auditing rule, including the latest updates from the FDA and what companies should be doing based on the rule. Here, in part four, Acheson and Bender begin addressing questions from the webcast’s live audience.

Jill: A few questions have come in, so we'll go ahead and take those. Some are related to today, some of them are just general questions that I know we like to always try to address. With that, let me just go ahead and throw out a couple of these questions at you. One question that came in is, “What is the fast-track company that has a major recall, or gets a bad grade on a third party audit? Do they lose their status?”

David: I think they will. There is definitely some language that is just being bantered around. There are certain things that will prevent you from being a positive VQIP program. If that's where this questionnaire is going, some of those are ongoing regulatory actions and import alerts, and recent recalls and those types of things. So yeah, I think that history, that track record will definitely have an impact on this.