483
Aparna Kalyan, M.D.FDA 483 - Aparna Kalyan, M.D. - February 18, 2025
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Record Details
An FDA inspection of Aparna Kalyan, M.D. in Chicago, IL, a clinical investigator, revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, safety laboratory tests were not performed for a subject across multiple study visits, and a subject received an incorrect dose of investigational product, leading to neutropenia.
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ID · c164d9b3-c286-40b7-8ad9-40908ec3c9cb