Hospira, Inc. - February 23, 2010
Issue Date
Feb 23, 2010
Region
Southeast
Category
Drug
$117.00
Address 1
8484 US 70 Bus Hwy North
City
Clayton
State
NC
Zip/Postal Code
27520-9465
Country
US
Inspection Range
Jan 26, 2010 - Feb 23, 2010
Pages
11
First Observation
Control procedures are not established which 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): Thomas R. Berry, Penny H. McCarver, and Hai Lien T. Phung