FDA Pressure Likely In Novartis OTC Plant Shutdown, Recalls

06 Feb 2012

• By Dan Schiff

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.

An FDA inspection report suggests the agency influenced Novartis Consumer Health Inc.’s decisions to cease production at its Lincoln, Neb., facility and recall OTC products.

While the company stated its actions were voluntary, precautionary measures, a Jan. 20 form 483 from FDA’s Lenexa,...