CIL Isotope Separations, LLC - Jan. 25, 2022
Issue Date
Jan 25, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Chris J. Larkins
Contact Title
Site Manager
Address 1
1689 Bumett Dr.
City
Xenia
State
OH
Zip/Postal Code
45385
Country
United States
Inspection Range
Jan 18, 2022 - Jan 25, 2022
Pages
6
First Observation
There is a failure to demonstrate that all equipment and materials used in the production of finished API, Urea-13C, are suitable for their intended use.
Investigator(s): Wen Ning Chan and Lauren N. Howard