483
Manisha H Shah, M.D.Manisha H Shah, M.D. – FDA 483, Feb 7, 2020
Record Details
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.
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