MedImmune Vaccines, Inc. - November 5, 2010
Issue Date
Nov 05, 2010
Region
Pacific
Category
Drug
$117.00
Address 1
3055 Patrick Henry Dr.
City
Santa Clara
State
CA
Zip/Postal Code
95054
Country
US
Inspection Range
Nov 01, 2010 - Nov 05, 2010
Pages
1
First Observation
The data used to support a maximum room temperature hold time of X hours for the Influenza B strain virus inoculums are inadequate in that the virus infectivity was not measured throughout this time period so it could not be determined if there was any significant decrease in the virus infectivity at the end of your proposed hold time.
Investigator(s): Anissa Cheung, Katie Harris, Mohammad Heidaran, and Nancy Waites