FDA EIR - Adam S. Giermasz, M.D., Ph.D. - July 17, 2020

An FDA inspection of Dr. Adam S. Giermasz, M.D., Ph.D., a Principal Investigator at UC Davis Clinical and Translational Science Center, was conducted from July 13-17, 2020. This comprehensive surveillance inspection, classified as a High Priority PDUFA Clinical Investigator Inspection under Compliance Program 7348.811, aimed to assess good clinical practice and data integrity for a specific study. The regulatory framework covered the conduct of clinical studies involving FDA-regulated products. The inspection included a data audit, review of investigator site files, and subject records. Notably, no Form FDA 483, indicating objectionable conditions, was issued at the inspection's conclusion. The main discussion item involved a three-month gap in the calibration certificates for the pharmacy’s temperature monitoring system. Management clarified this delay was due to awaiting a new freezer replacement, providing a "Note to File." The inspection confirmed that subject records were complete and organized, staff training was adequate, and monitoring activities were appropriately conducted. Investigational product accountability was also verified without discrepancies. No regulatory actions were required as a result of this inspection, reflecting an overall compliant status.