483
Manisha H Shah, M.D.FDA 483 - Manisha H Shah, M.D. - February 07, 2020
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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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ID · ca13e2d6-9846-4da8-976c-6a2a8bfd4fdc