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November 25, 2012

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United States - FDA 684-day delay

THE United States Food and Drug Administration took 684 days to issue a warning letter after uncovering infractions that could potentially harm patients at the pharmacy at the center of the deadly US meningitis outbreak, newly released documents show.

The New England Compounding Center (NECC) chastised the FDA in a letter dated January 5, 2007, telling the agency its response time was nearly 18 months longer than the FDA's average response, according to letters released under an open records request.

In the letter, NECC co-owner and chief pharmacist Barry Cadden said the delay "contradicts FDA's rhetoric."



 

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