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Category: Medical Device Industry

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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Jul
10

When Recalls are about More than Consumers: Managing Up and Down the Supply Chain

When there’s a recall, consumers think of the name on the package. Often that brand is the single company believed to be responsible, and that company is the one whose reputation is diminished. Perhaps nowhere is this more apparent than the food industry, where one ingredient from a supplier that consumers have never heard of can spark recalls across big brands and private labels.

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Jun
25

Closer FDA CBD Product Regulation – and Recalls – Appear Inevitable

We’ve seen sweeping regulatory changes before, but the FDA’s anticipated regulation of cannabis and CBD-infused products – a market expected to reach more than $20B globally by 2024 – promises to pose significant and unprecedented challenges to food and cosmetics manufacturers already using cannabidiol as an ingredient.

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Jun
11

Recalls in the Era of Fake News

Fake 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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