FDA Warns J&J Unit Over Insulin Pump Reporting Delays

Law360, New York (January 11, 2012, 7:02 PM EST) -- The U.S. Food and Drug Administration in a letter released Tuesday warned a Johnson & Johnson subsidiary to promptly correct its repeated failure to timely report adverse incidents related to its insulin infusion pumps in order to avoid regulatory action.

J&J unit Animas Corp. has violated federal regulations by failing to report to the FDA within 30 days incidents in which its insulin devices contributed to serious injury or death and by failing to have proper medical device reporting procedures in place, according to a warning...
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