FDA Exercises New FSMA Authority – What’s Next?

By Mike Rozembajgier For the first time since the passage of the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) recently exercised its authority and shut down operations at a peanut processing plant suspected of...


FDA still has mandatory recall authority and can shutter your facilities at a moment’s notice. And recent events warn us that the agency is not afraid to do just that. While you look ahead and plan for what future regulations have in store for your business, don’t forget to test your recall plans and keep a close eye on internal food safety practices.

It is more important now than ever before that you effectively prepare your staff on proper recall procedures and keep them up to speed on current and upcoming federal regulations. While mistakes happen that can trigger a recall event, it is how a company manages and responds to a recall that can determine whether FDA takes further action.

That’s why understanding the regulatory landscape and your corporate recall management plan is so critical to survival in this new regulatory era. It can mean the difference between keeping your business’ doors open and having your registration suspended.

Mike Rozembajgier is Vice President of Recalls for Stericycle ExpertRECALL™. Rozembajgier is responsible for all aspects of recall service offerings, including development of strategic recall business initiatives and product enhancements. He has more than 10 years of experience in the healthcare industry. Prior to joining ExpertRECALL, Rozembajgier held various management positions at Guidant Corp. (now Boston Scientific) and at Deloitte in the Strategic Consulting practice.

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