FDA 483 - Siyan Clinical Research - September 15, 2025

An FDA inspection was conducted at Anish Shah, M.D. Siyan Clinical Research in Santa Rosa, CA, on September 15, 2025. The inspection identified a key observation related to the conduct of a clinical investigation. The main issue was a failure to adhere to the investigational plan concerning rater blinding. Specifically, for visit 9 of subject ROH, Dr. Anish S. Shah, the Principal Investigator, completed both the rating scale and the investigator-rated diagnostic questionnaire. This practice violated the investigational plan, which required the rater to be blinded to the other rating scale's score, potentially compromising data integrity. This observation is reported under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. The FDA notes that these are initial inspectional observations, not a final determination of compliance. The firm is expected to review the observation and implement corrective actions, with the option to discuss these or any objections with FDA representatives or submit a response to the agency.