Able Labs updates on FDA inspection

New Jersey, USA-based Able Laboratories says that it has received from the Food and Drug Administration 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.

The ongoing disruption of the firm'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 Able's results and financial position. The company says it intends to continue to work proactively and cooperatively with the FDA to achieve resolution of the outstanding regulatory issues, but can give no assurance as to if or when it will be able to resolve them or resume manufacturing operations.