FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators. From the archives, here is the clinical inspection summary for Solosec (Secnidazole oral granules) submitted by Symbiomix Therpeutics. Three sites plus the CRO were inspected. Site inspections ranged from three to seven days. Site selection for inspection were driven by enrollment and site specific efficacy. Site inspections focused on verification of specific line listings from the submissions: subject screening, discontinued subjects, AEs, protocol deviations, and primary / secondary efficacy endpoints. The CRO inspection targeted data management and monitoring activities for ten specific sites. One site received a FDA Form 483.
Dr. Morgan was cited for:
- Failing to adhere to study eligibility criteria, specifically by enrolling one subject who had prior exposure to the investigational product from the Phase 2 study.