Genentech, Inc. - May 21, 2021
Issue Date
May 21, 2021
Region
Pacific
Category
Drug
$117.00
Contact Name
Timothy M. Brown
Contact Title
Vice President and General Manager
Address 1
4625 N.E. Brookwood Pkwy.
City
Hillsboro
State
OR
Zip/Postal Code
97124
Country
United States
Inspection Range
May 17, 2021 - May 21, 2021
Pages
2
First Observation
Control procedures are not established to monitor manufacturing processes that may be responsible for causing variability of the fill volume in the drug product vial.
Investigator(s): Barbara J. Breithaupt