FDA Inspection Summary: Bavencio™ (avelumab) submitted by EMD Serono

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 Bavencio (avelumab) submitted by EMD Serono. Four sites, the vendor responsible for the independent review committee of the study endpoint and the sponsor were inspected. Site inspections ranged from four to fourteen days, the vendor inspection lasted four days and the sponsor inspection ranged over eight days. Two sites plus the sponsor received FDA Form 483s.

Dr. Bhatia was cited for:

  • Failing to report a Serious Adverse Event (SAE) to the sponsor in the protocol required timeframes
  • Three subjects missed 20% of the protocol required post-infusion ECGs. (FDA notes that the site identified root cause of these missed ECGs and implemented a corrective action plan during the course of the inspection.)

Dr. Shih was cited for:

  • Failing to report adverse events per protocol, specifically 50 non-serious adverse events were not reported from the site to the sponsor.
  • Failure to administer protocol required premedications for two subjects

EMD Serono received a 483 for:

  • Failing to monitor the study properly, specifically one monitor failed to report five protocol deviations at one site relating to subjects not receiving protocol required premedications.
  • Failing to follow the investigational plan, specifically:
    • Failing to finalize the Clinical Operations Plan for the study until one year after the first subject was enrolled. This plan included site selection and monitoring. 
    • A SUSAR report was received at the CRO, but not submitted to FDA or other investigators for one month.