FDA 483 - John D. Gabriel, MD - October 22, 2013

John Gabriel, MD, a clinical research facility in North Richland Hills, TX, was issued a Form 483 with three observations following an FDA inspection. The inspection revealed significant deficiencies in the conduct of clinical investigations, including failures to adhere to investigational plans and protect subject welfare. Issues also encompassed inadequate investigational drug disposition records and inaccuracies in case histories.