Cook, Inc. - Sept. 14, 2021
Issue Date
Sep 14, 2021
Region
Central
Category
Device
$117.00
Contact Name
Eugene W. Baker
Contact Title
Vice President and General Manager
Address 1
750 N. Daniels Way
City
Bloomington
State
IN
Zip/Postal Code
47404 -9120
Country
United States
Inspection Range
Aug 30, 2021 - Sep 14, 2021
Pages
3
First Observation
Procedures for monitoring and control of process parameters for a validated process have not been
adequately established.
Investigator(s): Joseph R. Strelnik