FDA 483 - Fred K. Kurata, M.D. - March 30, 2023

Fred K. Kurata, M.D., a clinical investigator in Los Angeles, CA, was issued a Form FDA 483 following an inspection. The inspection revealed a failure to maintain adequate case histories for an investigation involving an investigational product. Specifically, records showed multiple ophthalmic exams were performed for different subjects on the same day and at the same time, indicating potential data integrity issues.