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Novartis OTC Plant Troubled By Quality Failures A Year After Shutdown

This article was originally published in The Tan Sheet

Executive Summary

FDA recorded nine observations – many of them repeats from 2011 and 2012 – on a form 483 during its early 2013 visit to Novartis Consumer Health’s facility in Lincoln, Nebraska. The observations cited inadequate consumer complaint handling and container closure stability testing.

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