ImClone Systems, L.L.C. - Aug. 21, 2020
Issue Date
Aug 21, 2020
Region
Central
Category
Drug
$117.00
Contact Name
Nellie D. Clark Eliza
Contact Title
VP Site Head of Manufacturing
Address 1
33 ImClone Dr.
City
Branchburg
State
NJ
Zip/Postal Code
08876-3904
Country
United States
Inspection Range
Jul 27, 2020 - Aug 21, 2020
Pages
6
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Tamil Arasu and Ko U. Min