FDA accepts Imation’s reply to warning
Imation of Oakdale, MN, announced June 11 that the Food and Drug Administration has accepted its plan for dealing with concerns outlined in a warning letter it received from the FDA last month (SCAN 6/10/98). The letter was the result of a
Imation of Oakdale, MN, announced June 11 that the Food and Drug Administration has accepted its plan for dealing with concerns outlined in a warning letter it received from the FDA last month (SCAN 6/10/98). The letter was the result of a scheduled FDA visit in April to Imation's laser printer manufacturing facility, where the agency discovered inadequate links between Imation's documentation systems. In its reply, the company detailed a consistent documentation system that satisfies FDA requirements and clarified the connections between its existing documentation systems.