Catalent Indiana, LLC - May 12, 2023
Issue Date
May 12, 2023
Region
Central
Category
Drug
$117.00
Contact Name
Scott Gunther
Contact Title
Senior Vice President of Quality Assurance & Regulatory Affairs
Address 1
1300 S. Patterson Dr.
City
Bloomington
State
IN
Zip/Postal Code
47403
Inspection Range
May 04, 2023 - May 12, 2023
Pages
4
First Observation
Written production and process control procedures are not followed or established in the execution of production and process control functions.
Investigator(s): Hyung-Yul Lee and Wayne Seifert