FDA warns Insightra on adverse event reports

The FDA warned Insightra Medical last month about how it handles reporting and investigating failure complaints concerning its intra-aortic balloon catheters. An FDA investigator inspected Insightra’s Irvine, Calif., facility in February and issued a Form 483 detailing the company’s failure to adequately establish procedures for receiving, reviewing, and evaluating complaints, according to a May 21 […]

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