FDA Clinical Inspection Summary:Mirvaso (brimonidine tartrate) submitted by Galderama research and development

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 Mirvaso (brimonidine tartrate) submitted by Galderama. Four sites were inspected. Inspections lasted from three days to over one month. Sites were inspected on the basis of enrollment and treatment response. One site received a FDA Form 483.

Dr. Jarratt was cited for:

  • Failing to conduct an investigation in accordance with the investigational plan, specifically:
    • Enrolling a subject without completing screening serum chemistry
    • A subinvestigator completed assessments of eighteen subjects prior to completing required training.
  • Failing to maintain adequate and accurate case histories, specifically
    • Site staff signed a reconsent document for one patient over a month after the patient signed the document.

At a different site, a study coordinator falsified one blood pressure reading. The investigator did not receive a 483 for this. FDA notes that the site had SOPs in place and the study coordinator was fired and the single data point did not contribute to efficacy and was not a safety concern. FDA notes that monitoring had promptly identified this issue and escalated it to the PI.