Orthocon Inc – FDA Warning Letter, Sep 9, 2010

An FDA inspection of Orthocon, Inc. from July to September 2010 identified objectionable conditions related to its role as sponsor for clinical studies of the Orthostat-L Hemostatic Bone Putty device. The inspection aimed to ensure compliance with federal regulations (21 CFR Part 812 and Section 520(g) of the Act) and protect human subjects. A serious violation was observed: Orthocon's failure to secure investigator compliance, as required by 21 CFR 812.46(a). Specifically, monitoring visits in 2008 revealed a principal investigator repeatedly enrolled and implanted the investigational device in subjects who met exclusion criteria, exposing them to potential adverse effects. Orthocon's written response stated belief in compliance and that subjects were not at risk. They reported revising internal policies (SOP-050, revision B), planning site monitoring during enrollment, implementing web-based electronic data capture for real-time data, and disqualifying the non-compliant investigator. However, the FDA deemed this response inadequate, noting a lack of detailed corrective and preventive action plans to prevent recurrence. Orthocon is required to provide, within 15 working days, detailed documentation of additional corrective actions, including policies, procedures, training, and projected completion dates, to address this violation and prevent future occurrences. Failure to comply may result in further regulatory action.