An FDA inspectional observation report hints at the depth of quality system problems plaguing Novartis Consumer Health Inc.’s Lincoln, Neb., facility, a site the company is downsizing through layoffs and outsourcing to third-party manufacturers.
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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.