The Food and Drug Administration is ordering J&J’s Animas Corp. unit to promptly provide a plan to rectify its failure to report within 30 days cases where its device may have caused or contributed to death or serious injury.
The FDA says inspectors found Animas never reported or delayed reporting on patients hospitalized with dangerously high blood sugar, respiratory failure and coma, and a life-threatening complication called diabetic ketoacidosis.
J&J says it will respond to FDA’s letter shortly.
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