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FDAnews Drug Daily Bulletin
Biogen Idec Gets 483 for Overlooking Particles
Aug. 5, 2013
The FDA handed Biogen Idec’s Cambridge, Mass. facility a Form 483 after the company released a drug substance destined for compounding that contained white particles. Biogen’s material review board recommended releasing the drug substance even though the lot contained particles later determined to be protein aggregates, the form reads.
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