FDA 483 - Paul R. Sieber, M.D. - October 23, 2019

An FDA inspection of Paul R Sieber Md in Lancaster, PA, identified significant deficiencies in the management of investigational drug disposition records. The firm failed to adequately document the use and return of investigational drugs for numerous subjects, with instances of missing drug bottles and apparent back-dating of records. These findings indicate a serious lack of control over investigational drug accountability.