FDA warning letter lifted for Marlborough facility
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Warning letters issued last year by the U.S. Food and Drug Administration (FDA) because of compliance problems found at AngioDynamics Inc. facilities in Marlborough and New York have been resolved, the company said Wednesday.
The warning letters were issued to the Albany, N.Y. company after compliance issues were identified during inspections in November 2014 at the Marlborough site, and another in Glen Falls, N.Y. Another warning letter issued in January 2011, after the company allegedly marketed one of its products without proper FDA clearance, was lifted last month.
AngioDynamics President and CEO Joseph M. DeVivo said in a statement that the company has worked diligently with the FDA to address all compliance issues.
“The resolution of these issues is a significant boost to AngioDynamics and improves our ability to drive the growth of the business, especially in international markets,” DeVivo said.
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