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University of Texas Southwestern Medical Center - Nov. 9, 2018

Issue Date

Nov 29, 2018

Region

Southwest

Category

Drug
$117.00

University of Texas Southwestern Medical Center

Contact Name

Mariana Dakanali

Contact Title

Assistant Professor/Regulatory Affairs Officer Cyclotron and Radiochemistry Program (CRP)

Form483 Address 1

2201 Inwood Dr.

Form483 Address 2

Form483 City

Dallas

Form483 State

TX

Form483 Postal

75253

Form483 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, Reba A. Gates