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...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.