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Category: Medical Device Industry

Mar
19

Recalls During the COVID-19 Pandemic

First 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.

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Nov
13

Product Recalls Stabilize, But an Upsurge is Expected

While U.S. product recalls were relatively flat from the second to third quarter, expect an upsurge in the weeks and months to come as regulators – under growing pressure from Congress and consumer groups – turn their attention to currently unregulated categories.  Part of that pressure on regulators is a result of past handling of product safety issues.

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Oct
22

Cannabis Recalled Without Federal Regulation

The product recall by Denver-based marijuana cultivator Bonsai Cultivation reminds us all of the unique regulatory dynamic facing the cannabis industry. In this case, the cultivator – working with state officials – pulled marijuana products off the market because they may contain elevated yeast and mold counts. The recall followed a Denver Department of Public Health & Environment examination of dried marijuana samples.

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Oct
09

FDA’s Recall Planning Guidance Offers Little New Insight

FDA 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)).

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Aug
22

Recalls Remain Steady as Regulators are in the Hot Seat

The big story from the Q2 2019 Recall Index we’ve just released isn’t as much about the number of events or units recalled as it is the recall environment companies are finding themselves in. While Congress focuses on safety-related regulatory processes at the CPSC, and FDA tries to find its way on matters related to cannabis and CBD oil, companies are finding a regulator that is stricter and more sensitive to pressure from lawmakers.

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