FDA 483 - ImClone Systems, LLC - March 09, 2018

An FDA inspection of ImClone Systems, LLC. d.b.a. Eli Lilly and Company in Branchburg, NJ, identified deficiencies in aseptic processing areas. The firm failed to conduct proper smoke studies for ISO 5 Bio Safety Cabinets and did not perform adequate media fills to simulate aseptic production operations, indicating issues with environmental monitoring and contamination prevention procedures.