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www.fdanews.com/articles/145219-biogen-idec-handed-483-for-8216-non-optimal-8217-components

Biogen Idec Handed 483 for ‘Non-Optimal’ Components

March 30, 2012

Components used to make Biogen Idec’s multiple sclerosis drug Avonex were not consistently shown to be suitable for use, drawing a Form 483 for the company’s North Carolina plant.

Lots of certain components used for Avonex (interferon beta-1a) were not appropriately qualified and thereby only support “non-optimal” viability, the Sept. 30, 2011, form states.

Investigators with the FDA’s Atlanta district office noted nine other observations, including a pair of instances in which Biogen failed to thoroughly review — and determine root cause for — an unexplained procedural change, whether or not a related drug substance batch was released.

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