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Category: Pharmaceutical 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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Sep
25

Investigation Underway, Generic Zantac Shipments Stopped. Recall Next? Almost Undoubtedly

Bloomberg News recently published a lengthy piece on how carcinogens are allegedly infiltrating the generic drug supply in the United States. The very next day, drug safety officials announced that they were investigating whether Zantac and its generic counterparts contain levels of the probable carcinogen N-Nitrosodimethylamine, or NDMA – the same chemical that was found in blood-pressure pills last year. Those pills were ultimately recalled, and those

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Sep
11

When it Comes to Your Supply Chain, Who is Your Weakest Link?

Perhaps the most recognizable supply chain challenge linked to a product recall is the Takata airbag recall, which has so far impacted 19 automakers and 37 million vehicles over the course of several years. Because of the growing global length and complexity of supply chains, most product recalls today bring added layers of liability and reputational risk for several companies. We discussed

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Sep
04

E-Cig Makers On the Top of FDA’s Most Wanted List

E-Cig Makers On the Top of FDA’s Most Wanted List Just in time for the new school year, US public health officials from FDA and CDC have issued a joint warning: avoid e-cigarettes and other vaping devices.

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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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