CSL Behring LLC - June 5, 2009
Issue Date
Jun 05, 2009
Region
Central
Category
Drug
$117.00
Address 1
1201 N. Kinzie Ave.
City
Bradley
State
IL
Zip/Postal Code
60915
Country
US
Inspection Range
Jun 01, 2009 - Jun 05, 2009
Pages
2
First Observation
The firm has not sufficiently validated the effectiveness of the automated optical inspection machine that it plans to use in its influenza vaccine pre-filled syringe packaging line.
Investigator(s): Samuel W. Labinjo, Russell K. Riley, Jennifer L. Schmidt, and Deborah M. Trout