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DEVICE DEVELOPER HIT WITH SECOND WARNING LETTER IN 18 MONTHS

Aug. 28, 2006

Fertility device developer Medelle failed to investigate adverse events, the FDA said in a warning letter. The agency also cited the firm for failing to turn records over to an FDA investigator.

The firm failed to maintain accurate, complete and current records for a clinical trial, "a repeat violation from the last inspection" that was cited in a previous warning letter dated Feb. 1, 2005.

"All we want to say is we are working diligently to address the issues in the warning letter and we are working on our response to the FDA," Medelle President and CEO Veronica Jordan said.

According to the latest warning letter, dated Aug. 2 and posted on the FDA's website Aug. 15, one subject was hospitalized for respiratory difficulties on April 14, but the form reporting this event was unsigned and undated. "There was no evidence that Medelle attempted to obtain the follow-up information, or that any evaluation of the event was made to determine the relationship of the event to the device," the warning letter stated. (http://www.fdanews.com/ddl/33_33/)