FDA Finds Another Example Of Quality Control Problems At Guidant
This article was originally published in The Gray Sheet
A recent FDA inspection of Guidant's cardiac rhythm management facilities in St. Paul resulted in one new observation about a potential quality control problem at the site, the company reported Feb. 23
You may also be interested in...
Boston Scientific estimates it will be ready by June for FDA to re-inspect its facilities to confirm that the quality-control problems cited in a sweeping Jan. 25 warning letter have been fixed
Guidant's board of directors has formally endorsed Johnson & Johnson's $21.5 bil. takeover bid while simultaneously agreeing to enter into discussions with Boston Scientific on its $25 bil. competing offer
Guidant is providing its 2005 Product Performance Report on its website as part of an effort to improve patient and physician access to device performance information, following a recent string of safety alerts