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

The FDA conducted an inspection of Dr. Linda D. Bosserman, M.D., located at Wilshire Oncology Medical Group, Inc. in La Verne, CA, from December 8 to December 22, 2010. This inspection was initiated by the CDER Good Clinical Practice Branch I due to a report of data falsification by a study coordinator at Dr. Bosserman's site for a Phase 3 study sponsored by BiPar Sciences, Inc. The inspection aimed to cover this specific study and audit other investigational new drug (IND) studies as necessary.

The inspection was conducted under Compliance Program 7348.811, focusing on Bioresearch Monitoring of Clinical Investigators. During the inspection, a two-item FDA-483 was issued to Dr. Bosserman for deficiencies in Good Clinical Practice (GCP). The violations included the failure to maintain adequate and accurate case histories and not conducting the investigation in accordance with the signed statement of the investigator and investigational plan.

Dr. Bosserman acknowledged the observations and indicated that corrective actions had been implemented promptly. She committed to providing a written response to the FDA, addressing the observations. No samples were collected, and no refusals were encountered during the inspection.

Dr. Bosserman, who has been with Wilshire Oncology Medical Group since 2003, holds a medical license in California and is a certified medical oncologist. This was her first inspection, and she is involved in multiple clinical trials as both a principal and sub-investigator.