FDA accepts Imation’s reply to warning

June 24, 1998

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.