Catalent Indiana, LLC - Sept. 1, 2022
Issue Date
Sep 01, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Andrew Espejo
Contact Title
General Manager
Address 1
1300 S. Patterson Dr.
City
Bloomington
State
IN
Zip/Postal Code
47403
Inspection Range
Aug 01, 2022 - Sep 01, 2022
Pages
18
First Observation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.
Investigator(s): Muna Algharibeh, Sandra A. Boyd, Eboni S. Funderburk, and Logan T. Williams