FDA WARNING_LETTER - Caton, John Jr., M.D. - August 20, 2010

An FDA inspection conducted between August 2 and August 20, 2010, at Willamette Valley Cancer Institute, reviewed Dr. John Caton, Jr.'s conduct of a clinical investigation (Protocol (b)(4)) involving investigational drugs (b)(4) and (b)(4). The inspection revealed significant violations of FDA regulations governing clinical investigations and human subject protection. Key deficiencies included the failure to ensure the investigation was conducted according to the investigational plan (21 CFR 312.60), evidenced by improper subject randomization and unrecorded adverse event attributes. The firm also failed to maintain adequate records of drug disposition (21 CFR 312.62(a)), with missing investigational product vials and undocumented drug transfers. Furthermore, Dr. Caton failed to promptly report unanticipated problems involving risk to human subjects or others to the IRB (21 CFR 312.66), specifically delaying reports of a subject's hospitalization and death. Lastly, informed consent was not obtained in accordance with 21 CFR part 50 (21 CFR 312.60, 50.27), as an unapproved template form was used. While Dr. Caton's response indicated future studies would be conducted under US Oncology Research with new SOPs, the FDA emphasized that this does not negate the clinical investigator's responsibilities. The letter requires a written response within fifteen working days detailing corrective actions to prevent similar violations, warning that failure to adequately respond may result in regulatory action.