FDA Warns Sorin Over Inadequate Incident Reports

Law360, New York (December 9, 2009, 6:21 PM EST) -- The U.S. Food and Drug Administration has warned Italian medical device maker Sorin Biomedica SpA over its failure to adequately submit reports for adverse events related to its defibrillation lead devices that occurred outside the U.S.

The FDA sent a warning letter to Sorin's facility in Saluggia, Italy, on Oct. 29 informing the company that during an inspection conducted from June 29 to July 2, an FDA official observed the company's “failure to develop, maintain and implement written Medical Device Reporting procedures” for malfunctions of its...
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