Amgen Manufacturing Ltd., Inc. - April 29, 2011
Issue Date
Apr 29, 2011
Region
Southeast
Category
Drug
$117.00
Address 1
Rd. 31, Km 24.6
City
Juncos
Zip/Postal Code
00777
Country
PR
Inspection Range
Apr 18, 2011 - Apr 29, 2011
Pages
5
First Observation
There is a failure to thoroughly review and unexplained discrepancy whether or not the batch has already been distributed.
Investigator(s): Rebecca E. Dombrowski and Jose R. Lopez