FDA Clinical Inspection Summary: Moxifloxacin (alternative formulation) submitted by Alcon

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 Moxifloxacin (alternative formula) submitted by Alcon. Two sites (out of 32 participating sites) were selected for inspection, on the basis of enrollment and their operation under a site management organization. Site inspections ranged over seven and ten days. One site received a FDA Form 483.

Dr. Christiansen was cited for:

  • Failing to maintain adequate IP accountability
    •  Received by dates in the IP log were incorrect for thirteen subjects
    • Return information was missing or left  blank for two subjects
  • Failing to follow the investigational plan
    • Age specific tests were not conducted for one subject
  • Failing to prepare and maintain adequate and accurate case histories
    • Three discrepancies were noted between source documents and the CRF