FDA Clinical Inspection Summary: Trintellix (vortioxitene hydrobromide) submitted by Takeda

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary for Trintellix (vortioxitene hydrobromide) submitted by Takeda. Five clinical sites were selected for inspection, along with the sponsor. Sites were selected on enrollment, contribution to treatment efficacy, potential underreporting of Serious Adverse Events (SAEs) and either no previous FDA inspections, or no inspections within the last two years. One site received an FDA Form 483.

Dr. Ruelens was cited for:

  • The drug accountability log contained math errors, leading to miscalculations for drug accountability for five subjects.
  • There were eight corrections on study records that obliterated the original entries.