FDA 483 - Chamindra Laverty - January 14, 2026

The FDA inspected UCSD Altman Clinical And Translational Research Institute in La Jolla, CA, and issued a Form 483. The inspection revealed that the firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan. Specifically, there were significant delays in the timely review of both laboratory results and (b)(4) results for an enrolled subject, indicating a serious deviation from protocol requirements.