AngioDynamics (NSDQ:ANGO) said today that the FDA closed out a pair of warning letters sent in 2011 and 2014, closing the book on all warning letters sent to the Latham, N.Y.-based medical device company.
AngioDynamics said the FDA also closed out a November 2014 letter sent after the agency received 55 complaints alleging the presence of hair in long-term-use catheter packaging. The bureau also closed out a May 2011 letter flagging problems with its Centros chronic hemodialysis catheter.
“The removal of the final warning letters is a reflection of the exceptional quality and operations teams we have today at AngioDynamics. Over the past 4 years, they have worked diligently with the FDA to fully address the issues and help to instill a culture within the company that is committed to quality and compliance,” president & CEO Joseph DeVivo said in prepared remarks. “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.”