FDA WARNING_LETTER - Linda D. Bosserman - December 22, 2010

An FDA inspection conducted from December 8-22, 2010, at Wilshire Oncology Medical Group, Inc., reviewed Dr. Linda D. Bosserman's conduct of four clinical investigations. The inspection, part of the Bioresearch Monitoring Program, concluded that Dr. Bosserman failed to adhere to applicable statutory requirements and FDA regulations governing clinical investigations. Key violations identified include: 1) Failure to personally conduct or adequately supervise clinical investigations (21 CFR 312.60), particularly for Protocols (b)(4) and (b)(4), leading to problems with case histories and required assessments. 2) Failure to maintain adequate and accurate case histories (21 CFR 312.62(b)), evidenced by altered ECG and informed consent forms, and duplicate records with discrepant dates for subjects in Protocols (b)(4) and (b)(4). 3) Failure to ensure investigations were conducted according to the investigational plan (21 CFR 312.60), specifically for Protocol (b)(4), where critical assessments like circulating tumor cells, pharmacokinetics, pharmacogenomics, and Quality of Life questionnaires were not performed for a subject. While Dr. Bosserman's response outlined corrective actions, including staff changes, training, and SOP updates, it was deemed inadequate due to the lack of submitted revised SOPs and insufficient detail on preventing recurrence. The FDA requires a written response within fifteen working days, including documentation of revised procedures and policies, to prevent potential regulatory action and ensure the integrity of ongoing or future studies.