Baxalta, Inc. - Nov. 2, 2018
Issue Date
Nov 02, 2018
Region
Pacific
Category
Drug
$117.00
Contact Name
Syed Abbas Yar-Khan
Contact Title
Vice President, Manufacturing Site Head, Los Angeles
Address 1
4501 Colorado Blvd.
City
Los Angeles
State
CA
Zip/Postal Code
90039
Country
United States
Inspection Range
Aug 23, 2018 - Nov 02, 2018
Pages
6
First Observation
Inadequate failure investigations, root cause analyses and corrective actions to preventive recurrences were conducted into in-process manufactured products bioburden excursions.
Investigator(s): Abby L. Mozeke-Baker and Omotunde O. Osunsanmi