Celltex Therapeutics Corp. - April 27, 2012
Issue Date
Apr 27, 2012
Region
Southeast
Category
Drug
$117.00
Address 1
12621 W Airport Blvd.
Address 2
Ste. 800
City
Sugarland
State
TX
Zip/Postal Code
77478
Country
US
Inspection Range
Apr 16, 2012 - Apr 27, 2012
Pages
9
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): Linda M. Hoover and Joel Martinez