Able Laboratories, Inc.

Pharmaceutical firm receives inspectional observations from U.S. FDA

Published in Lab Law Weekly, August 19th, 2005

Able Laboratories, Inc., (ABRX) announced that it had received from the U.S. Food & Drug Administration (FDA) a list of Inspectional Observations (Form FDA 483) made by the agency in connection with the events that led to the recall of its products and suspension of manufacturing operations, previously announced on May 23, 2005.

The ongoing disruption in the company's operations caused by its product recall and the suspension of manufacturing activities has had, and will continue to have, a material adverse effect on the company's results of operations and financial position. The company intends to continue to work proactively and cooperatively with the FDA to achieve...

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Source: Lab Law Weekly (2005-08-19)

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