FDA Warning Letter! Adequate Medical Records


An FDA warning letter was issued to John D. Gabriel, M.D. relating to “objectionable conditions observed during” the course of the inspection conducted at his clinical site between February 1 and 18, 2016. This letter highlights the importance of staying informed and collecting detailed medical histories for subjects enrolled in the clinical study before any tests are carried out. The Form FDA 483 outlines the investigator’s negligence to adhere to the investigation plan outlined in the protocol thereby failing to ensure subject safety during the clinical trial.

In the investigational plan it is specifically stated that for subjects lacking key laboratory data by the end of Visit 1 would be randomized later and “if the subject’s met drops in certain laboratory rates the dose would be reduced.

These requirements were ignored when study drug was administered to two subjects without having prior knowledge of the laboratory values of these subjects at the time of randomization. It was found that the two test subjects were initially overdosed with study drug thereby compromising subject safety. Furthermore, Dr. Gabriel carelessness can be noted when a subject was enrolled in the study and randomized without having the required medical reports.  

Despite the investigators acknowledgement that “the initial study drug dose should not have been determined without first obtaining the required laboratory results, and that a more thorough screening process should have been done prior to assigning study drug dose”, it cannot be overlooked that two subjects were overdosed due to the investigator’s oversight. The investigator administered dosage based on “subject-reported kidney history” and “assumptions about their diabetes medications”. Moreover, the investigator failed to provide not only “a corrective action plan that, if properly carried out, would prevent this type of violation in the future” but also enough details on how he will ensure compliance to protocol-specific requirements for other future studies.

This letter highlights the importance of conducting trials in accordance with the investigational plan and the importance of obtaining the medical records before enrolling the subject in the clinical trial. 

Thank you, from the Clinical Pathways team