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

During an inspection conducted from December 5-16, 2022, the U.S. Food and Drug Administration issued a Form 483 to Anish Shah, M.D., operating as Siyan Clinical Research. The inspection revealed significant observations regarding the conduct of a clinical investigation, indicating potential non-compliance with the Federal Food, Drug and Cosmetic Act.

The primary issues included a failure to prepare and maintain adequate and accurate case histories. Specifically, the FDA noted irregularities in vital sign reporting for investigational study drug administration, where original time entries were revised weeks later to appear within protocol-allowed windows. Similar non-contemporaneous and unexplained revisions were found in study drug compliance records. Furthermore, the firm created new versions of source records without revisions, moving the original, revised versions to a separate archive, raising concerns about data integrity.

Additionally, the inspection identified a failure to ensure the investigation adhered to the established protocol. This included the assessment of the primary efficacy endpoint (MADRS score) by a rater who was not blinded to safety assessments for all three study subjects, which was contrary to the investigational plan. There was also a failure to report prior medications to the sponsor as required by the protocol. Anish Shah, M.D. is expected to respond to these observations with corrective and preventive actions.