Ajinomoto Althea, Inc. DBA Ajinomoto Bio-Pharma Services - Jan. 16, 2023
Issue Date
Jan 16, 2023
Region
Pacific
Category
Drug
$117.00
Contact Name
Paul E. Ruther
Contact Title
Vice President of Drug Product Manufacturing
Address 1
6175 Lusk Blvd.
Address 2
(11040 Roselle St.)
City
San Diego
State
CA
Zip/Postal Code
92121
Inspection Range
Jan 11, 2023 - Jan 16, 2023
Pages
2
First Observation
Quality oversight of validation activities is inadequate.
Investigator(s): Michael R. Shanks and Yi Wang