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

Source: https://www.globalkeysolutions.net/records/483/anish-shah-md/f83dca2e-7f33-43ef-91c0-b60861656fec

> FDA 483 for Anish Shah, M.D. on December 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anish Shah, M.D.
- Inspection Date: 2022-12-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Documents

- [483 - 2025-09-15](https://www.globalkeysolutions.net/records/483/anish-shah-md/af99f9d4-353f-4937-9154-5767e5423b59)

## Related Officers

- [Kristin M. Abaonza](https://www.globalkeysolutions.net/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b