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Kos gets GMP warning letter on Niaspan, Advicor

Executive Summary

Kos is submitting a corrective action plan to FDA following a warning letter on Niaspan and Advicor good manufacturing practices violations. The Dec. 29 1warning letter follows an inspection at Kos' Edison, N.J., facility in July and August 2003. FDA cites failures to properly investigate dissolution and content uniformity failures and notes that similar problems were observed during an April 2002 inspection...

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