FDA 483 - Dr. A. Sharda - April 07, 2016
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An FDA inspection of A. Sharda, M.D. in Bangalore, India, revealed significant deviations from good clinical practice during a clinical study. The firm failed to maintain adequate and accurate case histories, did not conduct the investigation according to the approved plan, and had conflicts of interest within its Ethics Committee. Additionally, the disposition of investigational product was not properly documented, indicating severe issues with data integrity and study oversight.
ID · b7982b9c-9d1a-4ce4-8c67-6487bba8e10d