FDA EIR - SanBio, Inc. - March 04, 2022

An FDA inspection of SanBio's Mountain View, CA facility took place from February 28 to March 4, 2022. This routine sponsor surveillance inspection, initiated by the Center for Biologics Evaluation and Research (CBER) under Compliance Program Guidance Manual (CPGM) 7348.810, focused on Investigational New Drug (IND) #18745 for the product SB623, specifically the TBI-01 clinical trial. The inspection covered areas such as clinical investigator selection and monitoring, quality assurance, safety reporting, and data handling.No FDA Form 483, Inspectional Observations, was issued at the close of the inspection. However, two primary issues were verbally discussed with management. First, SanBio failed to report results for the TBI-01 study on ClinicalTrials.gov within the required one-year timeframe following the primary completion date (January 31, 2019), with results posted on December 27, 2021, and without submitting a certification of delay, extension, or waiver. Management acknowledged this oversight. Second, the company had missing annual reports for the TBI-01 IND, having not submitted separate reports for two years and mistakenly believing an annual report from another IND sufficed. SanBio management verbalized understanding of these regulatory obligations and committed to ensuring future compliance with timely reporting on ClinicalTrials.gov and submitting all required annual IND reports.