483
Shaila U. Gogate, M.D.FDA 483 - Shaila U. Gogate, M.D. - April 24, 2025
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Record Details
An FDA inspection of Shaila U. Gogate, M.D. in Denver, CO, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures in subject eligibility screening, inadequate review of adverse events, and issues with informed consent and maintaining accurate case histories. These findings indicate a lack of adherence to study protocols and regulatory requirements, potentially impacting data integrity and subject safety.
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