FDA Clinical Inspection Summary: Jentadueto (linagliptin and metformin) submitted by Boehringer Ingelheim

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 Jentadueto (linagliptin and metformin) submitted by Boehringer Ingelheim. Two sites were selected for inspection, based on geographic location (country providing 31% of enrolled patients) and randomization rate. Site inspections lasted four and fourteen days. One site received a FDA Form 483.

Dr. Srikanta was cited for:

  • Failing to adequately review lab reports, clinic  notes and patient diaries, specifically:
    • Patient diaries for two subjects were not signed off by site staff and review was not noted in clinic notes
    • One out of range lab report was not noted in clinic notes
    • Clinic notes did not correctly reflect the initiation of a concomitant medication
  • Failure to fully document the informed consent process in clinic notes. The FDA inspector specifically noted lack of documentation for Legally Authorized Representatives and illiterate subjects.