Hospira, Inc. - April 23, 2014
Issue Date
Apr 23, 2014
Region
Southwest
Category
Drug
$117.00
Contact Name
Andrew F. Knudten
Contact Title
Vice President of Operations, Plant Manager
Address 1
1776 Centennial Dr.
City
McPherson
State
KS
Zip/Postal Code
67450
Country
United States
Inspection Range
Apr 14, 2014 - Apr 23, 2014
Pages
4
First Observation
Control procedures are not established which 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): Tara L. Breckenridge Greene, Eric M. Mueller, Ashley A. Mutawakkil, and Cody D. Rickman