lmClone Systems, LLC - Aug. 25, 2022
Issue Date
Aug 25, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Nellie D. Clark
Contact Title
VP, Site Head of Manufacturing
Address 1
33 ImClone Dr.
City
Branchburg
State
NJ
Zip/Postal Code
08876
Inspection Range
Jul 26, 2022 - Aug 25, 2022
Pages
2
First Observation
There is a failure to control the disposition and availability of drug substances determined to be within the scope of deviation investigations before the satisfactory completion of evaluation by the quality unit.
Investigator(s): Kathleen Jordan and Edmund F. Mark Jr.