Getinge Wayne production unit receives FDA warning letter

The US Food and Drug Administration (FDA) has issued warning letter to Getinge for its Wayne production unit.

The FDA’s warning letter is issued on the basis of the manufacturing of vascular grafts, which it has inspected in the Wayne plant during the spring of 2010.

Getinge said that it has already recruited a task force who will take up the responsibility to eradicate the deficiencies that were observed by the FDA during its visit.

FDA informed the company that it will not grant any product approval for its Wayne production unit during the period the warning letter is in force.

Getinge’s Wayne production unit manufactures cardiac surgery products which are also said to be affected by the FDA’s action.