# FDA 483 - Anish Shah, M.D. - September 15, 2025

Source: https://www.globalkeysolutions.net/records/483/anish-shah-md/af99f9d4-353f-4937-9154-5767e5423b59

> FDA 483 for Anish Shah, M.D. on September 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anish Shah, M.D.
- Inspection Date: 2025-09-15
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: Siyan Clinical Research in Santa Rosa, CA, was inspected as a clinical investigator. The inspection revealed a significant issue with the conduct of an investigation, specifically a failure to maintain rater blinding as required by the investigational plan. This indicates a deviation from proper study execution protocols.

## Related Documents

- [483 - 2022-12-16](https://www.globalkeysolutions.net/records/483/anish-shah-md/f83dca2e-7f33-43ef-91c0-b60861656fec)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)
- [Linh Tu](https://www.globalkeysolutions.net/people/linh-tu/142c94dc-9538-4c52-9a5f-be27fc7c4f4b)

Company: https://www.globalkeysolutions.net/companies/anish-shah-md/d5a7202d-952f-4694-8125-f97cac875024

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df