AGC Biologics, Inc. -March 19, 2021
Issue Date
Mar 19, 2021
Region
Pacific
Category
Drug
$117.00
Contact Name
J.D. Mowery
Contact Title
Site Head and General Manager
Address 1
21511 23rd Dr. SE. and 22021 20th Ave. SE.
City
Bothell
State
WA
Zip/Postal Code
98021
Country
United States
Inspection Range
Mar 11, 2021 - Mar 19, 2021
Pages
14
First Observation
Manufacturing steps not included in the master batch records (MBR) are conducted without approval from the quality unit.
Investigator(s): Riley Myers, Nathaniel B. Phillips Sylvain, and Wayne Seifert