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Contamination Issues Featured in Second Quarter Warning Letters

This article was originally published in The Gold Sheet

Executive Summary

Fourteen second-quarter warning letters focused on microbial contamination issues as well as mix-ups, missing data, out-of-specification reporting procedures and more

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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

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

Enforcement on Steroids: FDA Delivers Twice the Drug GMP Warning Letters

Enforcement on steroids: As expected, FDA enforcement went into overdrive last year. The warning letter rate doubled and punishments were swift and harsh. But that was just the beginning. The agency expanded its field force, and after a few years of training, its new investigators will bring it on. No more dithering about Form 483 findings. Import alert hits Apotex 10 days after inspection. KV gets consent decree just four weeks after inspectors find it failed to file field alerts. Ranbaxy ANDA reviews halted by FDA's GMP concerns, even though EU and WHO saw nothing wrong. FDA's criminal investigators will coordinate more with the rest of the agency and others. Last year's 34 warning letters harped on the same issues as before, but with a new focus on foreign API makers. FDA's new foreign offices focus on data integrity in India and GMPs in China. Congress showers FDA with money but further constrains its regulatory discretion. Expect Dingell's Globalization Act to decorate 2012 PDUFA Christmas tree

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