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FDA Unhappy with Abbott, Again

Is Abbott the next GE? Or, perhaps we should ask, is the new Abbott the next old Abbott? FDA in a warning letter told the company it is not satisfied with its progress on correcting quality-control problems at a diagnostics-equipment plant in Irving, TX, reports the Chicago Tribune.

Oddly, the plant is one of several about to be transferred to GE, which has agreed to buy Abbott's diagnostics business, and GE recently had two plants shut down by FDA because of quality issues. The letter states that Abbott violated Good Manufacturing Practices, was slow in its Medical Device Reporting process, and failed to follow adequate purchasing procedures. Some of the problems identified on the latest inspection four months ago were the same ones identified in 2003 and 2004. This is the kind of thing that tries FDA's patience. Given Abbott's history with FDA -- it signed a consent decree, paid a $100 million fine, and pulled numerous products off the market in 1999 because of quality problems -- don't be surprised if the agency's patience runs out.

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