FDA 483 - Eric Wolfson, D.O. - August 09, 2018

An FDA inspection of Eric Wolfson, D.O. in Las Vegas, NV, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to follow the signed statement of investigator, enrollment of ineligible subjects, unperformed study procedures, and missing critical study documentation. Additionally, investigational drug disposition records were found to be inadequate, lacking proper accountability and reconciliation.