News about Blue Bell Creameries’ guilty plea and $19 million in federal fines linked to a deadly 2015 listeria outbreak that led to a series of ice cream recalls serves as a cautionary tale for all food companies operating in today’s punishing media and regulatory environment. Blue Bell, whose former CEO is also charged by the Justice Department with conspiracy to cover up safety problems at its plants, started with the best of intentions.
Continue ReadingThe faster a new medical device is approved, the sooner it’s likely to be recalled, according to a new research letter published in JAMA Internal Medicine. While the authors admit the data and findings have limitations, two conclusions they draw are startling: Medical devices approved by priority review were twice as likely to be recalled.
Continue ReadingFirst and foremost, we hope you and everyone close to you are well. We’re living through an unprecedented time and hopefully you’re able to find some calm and maintain connections. Like each of you, we’ve been working through the COVID-19 crisis, encouraging workers to follow the recommendations of federal, state and local health officials. But as crisis management professionals, we also can’t help but think about the long game.
Continue ReadingFDA started issuing draft industry guidance related to Hazard Analysis and Risk-Based Preventive Controls for Human Food (PCHF) in January 2018, but the 16 chapters are still a work in progress. Most recently, the FDA alerted the industry in the federal register that Chapter 14: Recall Plan is now available. The PCHF guidance specifies that companies and organizations “must establish a written recall plan for food that requires a preventive control (21 CFR 117.139(a)).
Continue ReadingFake product recalls – unlike other claims of so-called “fake news” – are exceedingly rare. But they are not without precedence. Just last year, a car dealership in Washington, D.C., was heavily fined by the Federal Trade Commission for sending fake recall warnings to car owners in the hopes of drumming up more business for the dealership’s repair shop. The dealership sent out bright red mailers that mimicked official recall notices from the National Highway Traffic Safety Administration (NHTSA).
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