Fenwal, a Fresenius-Kaby Company - April 25, 2013
Issue Date
Apr 25, 2013
Region
Southeast
Category
Drug
$117.00
Address 1
Carr 357, KM 0.8
City
Maricao
Zip/Postal Code
00606
Country
PR
Inspection Range
Apr 09, 2013 - Apr 25, 2013
Pages
7
First Observation
An NDA Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
Investigator(s): Noreen Muniz