UIHC PET Imaging Center - Nov. 8, 2018
Issue Date
Nov 08, 2018
Region
Southwest
Category
Drug
$117.00
Contact Name
David W. Dick
Contact Title
Clinical Associate Professor
Address 1
200 Hawkins Dr.
City
Iowa City
State
IA
Zip/Postal Code
52242
Country
United States
Inspection Range
Nov 05, 2018 - Nov 08, 2018
Pages
3
First Observation
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
Investigator(s): Robert J. Ham