AlloSource, Inc. - Aug. 23, 2012
Issue Date
Aug 23, 2012
Region
Southwest
Category
Drug
$117.00
Address 1
6278 S. Troy Cir.
City
Centennial
State
CO
Zip/Postal Code
80111-6422
Country
US
Inspection Range
Aug 13, 2012 - Aug 23, 2012
Pages
10
First Observation
Control procedures are not established to monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Marc A. Jackson Jr., Michael E. Maselli, and Zachery L. Miller