Baxalta US, Inc. - April 7, 2022
Issue Date
Apr 07, 2022
Region
Pacific
Category
Drug
$117.00
Contact Name
Stephen B. Hatke
Contact Title
Site Head Global Manufacturing and Supply
Address 1
1700 Rancho Conejo Blvd.
City
Thousand Oaks
State
CA
Zip/Postal Code
91320-1424
Country
United States
Inspection Range
Mar 29, 2022 - Apr 07, 2022
Pages
6
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Investigator(s): Lewis K. Antwi, Omotunde O. Osunsanmi, and Linda Thai