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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 […]

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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 […]

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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 […]

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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. With a growing number of cases of a severe lung disease being allegedly linked e-cigarette use, regulators are […]

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Aug
28

Pressure Rises at CPSC Over Home Elevators

The Consumer Product Safety Commission has been in the hot seat lately, criticized for its handling of recent children’s and infant product recalls. The latest chapter in the “failure to act” saga features in-home elevators that are putting children at risk. While it appears the agency is trying to regain control of the story by […]

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