FDA slaps Imation with warning on documentation issues at factory

Letter may be due to communication breakdown

The Food and Drug Administration zinged film and PACS vendor Imation with a warning letter on May 12, citing the company for procedural violations in the manufacture of laser imaging systems at its Oakdale, MN, plant. But the problem may be more a failure to communicate than a fundamental flaw in the manufacturing process, according to Imation spokesperson Jason Thunstrom.

"The warning that was issued really involves documentation versus product safety or reliability," he said.

Thunstrom noted that most or all of the necessary procedures mentioned in the letter are in place to meet FDA requirements, and the company simply did not properly convey that information to the FDA. Some of the confusion may have resulted from Imation's recent move of its manufacturing operation from a location in southern Minnesota to one that is closer to its Oakdale headquarters. A routine inspection of this new facility by the FDA turned up the problems.

"The bottom line is that (the FDA investigator) was not able to see significant links between the several documentation systems that we use in our manufacturing operation," he said.

Although the company is not overly concerned about the problem, executives do not take the warning letter lightly.

"We-like the FDA-believe that the documentation is just as important as operational safety, because they go hand-in-hand," Thunstrom said.

The letter underscores the importance of a proper response from Imation by alluding to the possibility of the government seizing inventory, obtaining a court injunction against further marketing of the products involved, and civil monetary penalties. Thunstrom believes, however, that the verbiage is more likely boilerplate than a threat aimed specifically at Imation.

"That is language that you would see in any of their warning letters," he said.

In fact, the FDA seldom resorts to such actions, despite the hundreds of warning letters the agency has sent out over the last few years. And Imation, as of press time, was still within the time frame for response given by the FDA.

Taking into account the Memorial Day weekend, executives calculated they had until June 4 to put a complete response in the hands of FDA officials. Thunstrom expected the company would convey a response satisfactory to FDA requirements before the deadline.