Getinge receives warning letter from the FDA concerning its production unit in Wayne
Getinge’s production unit in Wayne, New Jersey, US, has received a warning letter from the US FDA (Food and Drug Administration). The warning letter originates from an inspection performed by the authority on the Wayne plant during the spring of 2010. The FDA’s observations and remarks relate to the manufacture of vascular grafts. Because the operation in Wayne is also involved in the production of some of the Group’s cardiac surgery products, these products will also be affected by the action, since the warning letter is addressed to the production company as such. The warning letter