Baxalta US, Inc. (Takeda) - May 31, 2023
Issue Date
May 31, 2023
Region
Pacific
Category
Drug
$117.00
Contact Name
Babak Haghiri
Contact Title
Vice President, Manufacturing Site Head, Los Angeles
Address 1
4501 Colorado Blvd.
City
Los Angeles
State
CA
Zip/Postal Code
90039
Inspection Range
May 22, 2023 - May 31, 2023
Pages
9
First Observation
Your firm's manufacturing deviation investigation and out of specification (OOS) result investigation are deficient.
Investigator(s): Laurel A. Beer and Eileen A. Liu