Home » Site Investigator’s Failure Leads to Sponsor Warning
Site Investigator’s Failure Leads to Sponsor Warning
Orthocon has received a warning letter because a principal investigator in a 2007 clinical trial of its Orthostat-L hemostatic bone putty failed to adhere to the selection criteria for subjects. During two site monitoring visits in 2008, Orthocon’s contract research organization noted that the investigator had enrolled subjects who didn’t meet eligibility criteria. As a result, the FDA says the Irvington, N.Y., company “failed to secure the investigator’s compliance and allowed subjects to be put at risk for potential adverse effects.” Orthocon disagreed with the FDA’s conclusion, saying in its response to an inspection last year that it believes it complied with its sponsor obligations.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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