FDA 483 - O'Barr, Thomas MD - November 30, 2017

An FDA inspection of O'Barr, Thomas MD, a clinical investigator in Marietta, GA, revealed significant deficiencies in the conduct of nonclinical laboratory studies and record retention. The firm failed to adhere to study protocols regarding serious adverse event reporting, subject testing, and medication documentation. Additionally, required original records, such as ECG and lab reports, were not consistently retained.