John Caton Jr – FDA EIR, Aug 20, 2010

An FDA inspection of John Caton, Jr., located in Springfield, OR, was conducted from August 2 to August 20, 2010. This comprehensive, for-cause inspection, initiated under the Bioresearch Monitoring Compliance Program (CP 7348.811) and in response to a complaint, focused on clinical investigator data validation. The inspection identified numerous significant violations of regulatory requirements during the conduct of a research study.Key issues outlined in the Form FDA 483 included Dr. Caton's failure to conduct the investigation according to the signed statement and investigational plan, specifically regarding drug accountability and pharmacy records. There was a failure to adequately review laboratory reports and adverse events for subjects, and unanticipated problems involving human subject risk were not promptly reported to the Institutional Review Board (IRB). Furthermore, investigational drugs were not prepared and administered by appropriately trained staff. Inadequate case histories were noted, lacking proper documentation of serious adverse events, progress notes, and the clinical significance of out-of-specification lab values. The informed consent process was also deficient, with a failure to use and properly obtain an IRB-approved informed consent form, which lacked essential contact information for participants' questions.Dr. Caton stated he would provide a written response to the FDA 483 observations within 15 business days. He was informed of potential legal sanctions under the Food, Drug and Cosmetic Act, including disqualification, which he indicated he anticipated.