FDA 483 - Anjay Rastogi, MD, PhD - May 21, 2021

An FDA inspection of Anjay Rastogi, MD, PhD, a clinical investigator in Los Angeles, CA, revealed significant deficiencies in maintaining adequate and accurate case histories. Specifically, documents were signed as assessed before all information was available, and adverse events noted in source documents were not recorded in the electronic case report forms. These findings indicate a failure to ensure data integrity and complete record-keeping during clinical investigations.