FDA 483 - Namita A. Goyal, M.D. - June 23, 2023

An FDA inspection of Namita A. Goyal, M.D. in Orange, CA, revealed multiple significant deficiencies in the conduct of clinical trials. The firm failed to adhere to the signed investigator statement, obtain legally effective informed consent, and promptly report serious adverse events. Additionally, the inspection found issues with obtaining IRB approval for research changes and maintaining adequate and accurate case histories.