Amneal Pharmaceuticals LLC - Nov. 13, 2013
Issue Date
Nov 13, 2013
Region
Central
Category
Drug
$117.00
Contact Name
David Miller
Contact Title
VP, Quality Management
Address 1
209 Mclean Blvd.
City
Paterson
State
NJ
Zip/Postal Code
07504-1005
Country
United States
Inspection Range
Nov 05, 2013 - Nov 13, 2013
Pages
1
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): Michael R. Klapal