Dendreon Pharmaceuticals, LLC - Aug. 10, 2023
Issue Date
Aug 10, 2023
Region
Pacific
Category
Drug
$117.00
Contact Name
Bruce G. Johnson
Contact Title
Vice President, IMF Operations
Address 1
1700 Saturn Way
City
Seal Beach
State
CA
Zip/Postal Code
90740-5618
Inspection Range
Aug 02, 2023 - Aug 10, 2023
Pages
6
First Observation
Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
Investigator(s): Burnell M. Henry, Susan M. Jackson, and Latorie S. Jones