FDA Warns Alere Over Weak Response To Manufacturing Errors

Law360, New York (October 24, 2012, 3:50 PM EDT) -- The U.S. Food and Drug Administration on Monday hammered Alere Inc. in a lengthy warning letter that spotlighted numerous failings in the company's response to manufacturing errors that this year prompted sizable recalls of medical devices used to diagnose heart problems.

The 5,400-word letter called attention to at least 18 shortcomings in the Massachusetts-based company’s efforts to address FDA concerns that were voiced amid a pair of recalls covering 1.7 million Triage test kits that screen for heart attacks, heart failure and other ailments.

Alere hasn’t...
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