University of Texas Southwestern Medical Center - Nov. 9, 2018
Issue Date
Nov 29, 2018
Region
Southwest
Category
Drug
$117.00
Contact Name
Mariana Dakanali
Contact Title
Assistant Professor/Regulatory Affairs Officer Cyclotron and Radiochemistry Program (CRP)
Address 1
2201 Inwood Dr.
City
Dallas
State
TX
Zip/Postal Code
75253
Country
United States
Inspection Range
Nov 05, 2018 - Nov 09, 2018
Pages
10
First Observation
Controls are not in place to assure that a complete record of all data obtained in the course of testing PET drug products, materials and/or components are kept.
Investigator(s): Jason Caballero and Reba A. Gates