FDA 483 - Anish Shah, M.D. - December 16, 2022

An FDA inspection of Anish Shah, M.D. in Santa Rosa, CA, a clinical investigator, revealed significant data integrity issues and failures to adhere to the investigational plan. Observations included irregularities in vital sign reporting, non-contemporaneous record revisions, and the creation of altered study records. Additionally, the firm failed to conduct assessments as blinded and did not report all required prior medications to the sponsor.