Genzyme - March 18, 2015
Issue Date
Mar 18, 2015
Region
Pacific
Category
Drug
$117.00
Contact Name
David A. Carlson
Contact Title
Senior Director Manufacturing
Address 1
2625 162nd St. SW
City
Lynnwood
State
WA
Zip/Postal Code
98087
Country
United States
Inspection Range
Feb 18, 2015 - Mar 18, 2015
Pages
14
First Observation
The quality unit failed to establish adequate controls to prevent the introduction of microorganisms during the production of sargramostim BDS as evidenced by non-host contamination events.
Investigator(s): Barbara J. Breithaupt, Lynda L. Perry, James S. Stuart, and Jen-Jen Sui