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STAT Plus: FDA slams Akorn for a laundry list of manufacturing problems that put patients at risk

For all the talk lately about quality control problems with some drugs made in India, one has to look no further than the nation’s medicine chest for an example of egregious manufacturing practices.

In a lengthy and especially stern warning letter, the Food and Drug Administration scolded Akorn (ACRX) — which has faced long-running production issues at several facilities — for a laundry list of poor actions that was found during an inspection of a New Jersey plant last summer. And the issues bolster the concerns cited by Fresenius for backing away from its $4.7 billion acquisition of the troubled company last year.

Continue to STAT Plus to read the full story…

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