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FDA Pressure Likely In Novartis OTC Plant Shutdown, Recalls

This article was originally published in The Tan Sheet

Executive Summary

FDA inspectors were in Novartis Consumer Health’s Lincoln, Neb., plant in December and January, as the company was deciding to halt production and recall products. An inspection report notes 10 observations – eight of them repeats from FDA’s visit in mid-2011.

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J&J Bit Off More Than McNeil Could Chew In 2006 Pfizer OTC Acquisition

McNeil scaled up its manufacturing “volume and complexity substantially” following J&J’s acquisition of Pfizer’s consumer business in 2006, says McNeil Consumer VP Shane Freedman. “Just a few years later, we had the recalls” that led eventually to a consent decree with FDA,” he says.

J&J Bit Off More Than McNeil Could Chew In 2006 Pfizer OTC Acquisition

McNeil scaled up its manufacturing “volume and complexity substantially” following J&J’s acquisition of Pfizer’s consumer business in 2006, says McNeil Consumer VP Shane Freedman. “Just a few years later, we had the recalls” that led eventually to a consent decree with FDA,” he says.

J&J Bit Off More Than McNeil Could Chew In 2006 Pfizer OTC Acquisition

McNeil scaled up its manufacturing “volume and complexity substantially” following J&J’s acquisition of Pfizer’s consumer business in 2006, says McNeil Consumer VP Shane Freedman. “Just a few years later, we had the recalls” that led eventually to a consent decree with FDA,” he says.

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