# FDA 483 - Manisha H Shah, M.D. - February 07, 2020

Source: https://www.keypedia.com/records/483/manisha-h-shah-md/ca13e2d6-9846-4da8-976c-6a2a8bfd4fdc

> FDA 483 for Manisha H Shah, M.D. on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Manisha H Shah, M.D.
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Dr. Manisha H Shah, a clinical investigator in Columbus, OH, received an FDA Form 483 citing a significant deviation from an investigational plan. The inspection revealed that required study assessments and questionnaires were not performed for multiple subjects across various cycles of a clinical trial. This indicates a failure to adhere to the established study protocol.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kathryn-l-suttling/2d4695ca-5ec3-4658-8f46-101cec4ca41d)

Company: https://www.keypedia.com/companies/manisha-h-shah-md/d3ab194a-67fd-4537-b28b-c1d568441bc6

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22