483
ImClone Systems, LLCFDA 483 - ImClone Systems, LLC - March 09, 2018
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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.
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ID · 15bc1098-5ad2-4372-9bdf-209468afb7a5