FDA Clinical Inspection Summary: DaTSCAN (Ioflupane) submitted by GE Healthcare

FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for DaTSCAN (Ioflupane) submitted by GE Healthcare. Two sites, plus the unnamed CRO managing independent review of efficacy were selected for inspection. Sites were selected based on contribution to efficacy effect. All inspections were four days long. The unnamed CRO was issued a FDA Form 483.

The CRO was cited for failing to comply with the investigational plan, specifically in failing to retain independent reader training records as specified in the protocol.