FDA 483 - Kashinath G Yadalam M D - October 06, 2011

An FDA inspection of Kashinath G Yadalam M D, a clinical investigator in Lake Charles, LA, revealed significant deficiencies in maintaining adequate and accurate case histories and adherence to investigational plans. The firm failed to properly document subject observations and medication histories, and lacked a system to prevent the enrollment of ineligible subjects in clinical trials. These issues indicate a lack of control over critical aspects of clinical research.