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Advantage Dose's GMP Issues Mirrored Earlier Problems Affecting Repackers

This article was originally published in The Gold Sheet

Executive Summary

Advantage Dose case reflects major repacker recalls of the past

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Record Drug Recall Totals for 2009 Resulted from GMP Breakdowns

A deluge of drug recalls set a record in 2009. With the past four years now among the top five for recalls, it suggests drug quality could be in a period of decline. Last year's record reflects GMP breakdowns at a drug repacker and several manufacturers that were identified during FDA inspections and led to a variety of sanctions, including warning letters, consent decrees and an import alert. Congress is looking to let FDA mandate recalls, which means the rain of recalls could grow even heavier. Meanwhile, FDA adds suspensions to its enforcement arsenal. International recalls remain rare, though that could change as FDA ramps up enforcement abroad

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