FDA 483 - Kevin B. Kim, Clinical Investigator - October 16, 2013

An FDA inspection of Kevin B. Kim, Clinical Investigator in Houston, TX, revealed significant deficiencies in clinical trial conduct. The observations included failures to obtain proper informed consent, deviations from the investigational plan, and inadequate investigational drug disposition records. These issues indicate a lack of adherence to regulatory requirements for human subject protection and clinical study management.