Amgen, Inc. - March 29, 2013
Issue Date
Mar 29, 2013
Region
Southwest
Category
Drug
$117.00
Address 1
4000 Nelson Rd.
City
Longmont
State
CO
Zip/Postal Code
80503
Country
US
Inspection Range
Mar 18, 2013 - Mar 29, 2013
Pages
2
First Observation
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that components, drug product containers, closures and in-process materials conform to appropriate standards of identity, strength, quality and purity.
Investigator(s): Erika V. Butler, Steven C. Madzo, and Zachary L. Stamm