SOFIE Co. - Feb. 5, 2019
Issue Date
Feb 05, 2019
Region
Pacific
Category
Drug
$117.00
Contact Name
Hai M. Vu
Contact Title
Facility Manager
Address 1
5900 Obata Way
City
Gilroy
State
CA
Zip/Postal Code
95020-7065
Country
United States
Inspection Range
Feb 01, 2019 - Feb 05, 2019
Pages
3
First Observation
You did not follow procedures to ensure that each batch or sub-batch of a PET drug was not given final release until a designated qualified individual authorized the final release by dated signature.
Investigator(s): Lucila B. Nwatu