Baxalta US, Inc. - Jan. 17, 2020
Issue Date
Jan 17, 2020
Region
Pacific
Category
Drug
$117.00
Contact Name
Charles M. Nelson
Contact Title
Site Lead
Address 1
1700 Rancho Conejo Blvd.
City
Thousand Oaks
State
CA
Zip/Postal Code
91320
Country
United States
Inspection Range
Jan 08, 2020 - Jan 17, 2020
Pages
11
First Observation
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate specification as a condition of for their approval and release.
Investigator(s): Natalya M. Ammyeva, Eileen A. Liu, and Omotunde O. Osunsanmi