Fenwal International, Inc. - Feb. 24, 2012
Issue Date
Feb 24, 2012
Region
Southeast
Category
Device
$117.00
Address 1
Carr 357, Km 0.8
City
Maricao
Zip/Postal Code
00606
Country
PR
Inspection Range
Jan 24, 2012 - Feb 24, 2012
Pages
6
First Observation
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Laiza V. Garcia