Fenwal International, Inc. - February 2, 2009
Issue Date
Feb 02, 2009
Region
Southeast
Category
Drug
$117.00
Address 1
Carr 357
Address 2
Km 0.8
City
Maricao
State
PR
Zip/Postal Code
606
Country
US
Inspection Range
Jan 21, 2009 - Feb 02, 2009
Pages
2
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): Noreen Muniz