FDA 483 - UCLA Medical IRB 1 (OHRPP) - June 26, 2019

UCLA Medical IRB 1 (OHRPP) in Los Angeles, CA, was inspected by the FDA, resulting in one observation. The inspection found that the Institutional Review Board failed to include at least one member with nonscientific concerns during a regular review meeting. This deficiency was noted during a meeting where initial research and modifications were approved or deferred.