FDA 483 - InnAVasc Medical, Inc. - June 06, 2019

An FDA inspection of InnaVasc Medical, Inc. in Durham, NC, revealed significant deficiencies in record-keeping for adverse device effects. The firm failed to maintain complete records of verbal reports from clinical sites concerning anticipated or unanticipated device events, including device abandonment and explant. This indicates a serious lapse in tracking critical safety information for investigational devices.