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

An FDA inspection of clinical investigator Dr. Kashinath G. Yadalam, operating as Lake Charles Clinical Trials, L.L.C., was conducted from September 26 to October 6, 2011. The inspection assessed adherence to Good Clinical Practice (GCP), Human Subject Protection (HSP), and Financial Disclosure regulations, aligning with Compliance Program 7348.811 for Clinical Investigators.

Key violations identified on an FDA-483 included a failure to maintain adequate and accurate case histories. This manifested as insufficient documentation of the investigator's observations during inpatient hospitalizations and discrepancies between non-study and study medication records, leading to inaccurate medical histories. A critical finding was the enrollment of an ineligible subject due to prior experimental drug treatment within a prohibited timeframe, highlighting an inadequate system to prevent such protocol deviations. Other issues discussed included a general lack of investigator progress notes for outpatient evaluations, failure to explicitly identify certain subject populations in IRB submissions, and reliance on subject-reported medical histories over verifiable medical records for eligibility.

In response, Dr. Yadalam implemented new Standard Operating Procedures (SOPs) to improve documentation of investigator oversight for both inpatient and outpatient visits. He also established procedures for obtaining and retaining comprehensive patient medical and study participation histories to prevent future enrollment errors. Dr. Yadalam committed to a full review of existing records, correction of identified discrepancies, and providing a written response to the FDA outlining corrective actions.