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# Clinical Investigation Didn’t Follow Plan: FDA
- URL: https://www.fdaweb.com/clinical-investigation-didnt-follow-plan-fda/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:19:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156019

FDA says a 12/5-12/16/2023 Bioresearch Monitoring Program inspection at Siyan Clinical Research, maintained by **Anish Shah** in Santa Rosa, CA, found objectionable conditions. A 12/12/2023 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/anish-s-shah-mdsiyan-clinical-research-674073-12122023?ref=fdaweb.com) says Shah failed to ensure that the redacted investigation was conducted according to the investigational plan.

“While we acknowledge the actions that your site has taken and plans to take,” the agency says, “your response is inadequate because you did not include sufficient details about your corrective action plan…. We emphasize that as the clinical investigator, it is your responsibility to ensure that the study is conducted in accordance with the investigational plan and to ensure the integrity of the study data.”

Shah was told to respond with a list of specific actions he has taken to prevent the violations in the future.