Amgen - June 6, 2016
Issue Date
Jun 06, 2016
Region
Pacific
Category
Drug
$117.00
Contact Name
Valerie Whelan
Contact Title
Executive Director Quality Site Head
Address 1
One Amgen Center Dr.
City
Thousand Oaks
State
CA
Zip/Postal Code
91320
Country
United States
Inspection Range
Mar 31, 2016 - Jun 06, 2016
Pages
1
First Observation
The information provided does not support that existing procedural controls and process containment are adequate to prevent cross-contamination of drug substance by a potent biological product.
Investigator(s): Bo Chi, Steven Fong, Jun Park, Joel Welch, and Marcus F. Yambot