Tablet Turbulence at Novartis Plant Prompts Recall, New 483

A new Form 483 for Novartis Consumer Health’s Lincoln, Neb., facility cites a litany of manufacturing failures and instances of tablets gone wild, with products found in odd areas of the plant’s packaging line — GMP deficiencies that prompted a nationwide recall last month. The Jan. 20 form, which followed a month-long inspection of the troubled manufacturing facility, also cites a huge backlog of “major” customer complaints of chipped and mix-matched meds that FDA inspectors said have gone uninvestigated since at least August.
Drug GMP Report