FDA 483 - TriReme Medical, LLC. - October 30, 2019

ReReme Medical, LLC, a sponsor in Pleasanton, CA, was cited for deficiencies during an FDA inspection related to an investigational study. The firm failed to ensure proper monitoring, specifically lacking documentation for follow-up on adverse event queries. Additionally, the inspection revealed issues with investigator agreements, including incomplete financial disclosure commitments, inaccurate financial disclosures, and agreements not being obtained prior to investigator participation.