FDA Clinical Inspection Summary: Zykadia (ceritinib) submitted by Novartis

FDA did not post any warning letters to clinical trial Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary for Zykadia (ceritinib) submitted by Novartis. Three sites, a vendor and the sponsor were inspected. Site inspections ranged from eight days to one month. One site and the sponsor received FDA Form 483s.

Dr. Mehra was cited for:

  • Failing to follow the investigational plan, specifically:
    • Enrolling one subject that did not meet specific study inclusion criteria
    • Failing to enter tumor assessment measurements into the eCRF for one subject at one cycle visit
    • Failing to perform five ECGs as required by protocol

The sponsor was cited for:

  • Failing to properly monitor the study, specifically:
    • Failing to report all protocol deviations in line listings (14 missed pregnancy tests for five subjects at three sites)
    • Two missing monitoring visit reports for one site