Amgen Manufacturing, Limited - September 11, 2009
Issue Date
Sep 11, 2009
Region
Southeast
Category
Device
$117.00
Address 1
Rd 31
Address 2
KM 24.6
City
Juncos
State
PR
Zip/Postal Code
777
Country
US
Inspection Range
Jul 27, 2009 - Sep 11, 2009
Pages
2
First Observation
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Investigator(s): Jose E. Melendez and Donald C. Obenhuber