Teleflex Inc. (NYSE:TFX) announced that it successfully resolved all outstanding issues cited in a FDA Warning Letter regarding quality systems control issues at its subsidiary Arrow International.
The Warning Letter was sent in October 2007, just weeks after Limerick, Pa.-based Teleflex completed its acquisition of Arrow.
The issues cited in the warning occurred prior to the acquisition, according to company officials, and Teleflex got to work addressing the FDA’s concerns right away.
The company received word from the FDA that all issues have been sufficiently resolved, according to today’s release.
This marks more good news for newly converted pure-play medical device maker Teleflex, which touted FDA clearance for an antegrade catheter in March.