Gambro Renal Division Gets Second Warning Letter Of The Still-New Year
This article was originally published in The Gray Sheet
Executive Summary
Two warning letters sent to Gambro in the past two months signal FDA's increasing alarm at how the firm's renal products division handles adverse event reports
You may also be interested in...
Gambro Promises Corrective Actions To FDA, Makes Plans To Go Private
Gambro says it will release new software for its Prisma hemodialysis machine by this summer to address safety concerns identified by FDA
Gambro Promises Corrective Actions To FDA, Makes Plans To Go Private
Gambro says it will release new software for its Prisma hemodialysis machine by this summer to address safety concerns identified by FDA
Boston Scientific Stung With Across-The-Board Corporate Warning Letter
FDA is targeting Boston Scientific with a rare and far-reaching enforcement measure that could prevent some of the firm's investigational products from receiving market approval in the near term