FDA EIR - Ruemu E. Birhiray, M.D. - September 04, 2015

An FDA inspection of Ruemu Birhiray / Hematology Oncology of Indiana (HOI) took place from August 31 to September 4, 2015, as a follow-up to a 2013 inspection that resulted in a Warning Letter in April 2014. The previous letter cited issues including inadequate informed consent, failure to report adverse events promptly to the IRB, and conducting investigations not in accordance with the plan. This current inspection, under Compliance Program 7348.811 for Clinical Investigators, assessed corrective actions for protocols (b)(4) and (b)(4). While some prior deficiencies were partially or fully addressed, new violations were identified, leading to a Form FDA 483. Main violations included failure to conduct investigations in accordance with the investigational plan (21 CFR 312.60), specifically regarding undocumented urine sample collections for a study protocol. There was also a failure to maintain accurate case histories (21 CFR 312.62(b)) due to missing documentation for these samples. A critical issue was the failure to assure IRB compliance (21 CFR 312.66) by inaccurately reporting to Institutional Review Boards that previous FDA audits, Form 483s, or Warning Letters had not been received. Dr. Birhiray acknowledged the findings, committing to a written response to the FDA 483 within 15 days, and promising to implement corrective actions such as developing comprehensive visit checklists, reorganizing source documents, revising and ensuring consistent training on Standard Operating Procedures, and ensuring accurate reporting to IRBs.