AGC Biologics, Inc. - Feb. 10, 2023
Issue Date
Feb 10, 2023
Region
Pacific
Category
Drug
$117.00
Contact Name
Kevin Ingham
Contact Title
Site Head & General Manager
Address 1
21511 23rd Dr. SE.
City
Bothell
State
WA
Zip/Postal Code
98021
Inspection Range
Feb 02, 2023 - Feb 10, 2023
Pages
15
First Observation
Written records of investigations into unexplained discrepancies, the failure of a batch or any of its components to meet specifications, do not always include the appropriate conclusions and follow-up.
Investigator(s): Michael Araneta, Teegan Dellibovi-Ragheb, Andrew Haack, Brian M. Janelsins, Charles Yuan-Chia Kuo, and Zhong Li