483
ImClone Systems, LLCFDA 483 - ImClone Systems, LLC - July 27, 2023
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Record Details
ImClone Systems LLC, a drug substance manufacturer in Branchburg, NJ, received eight observations during an FDA inspection. Deficiencies were noted in QC sample management, computerized system controls, investigation processes, and personnel training. Additionally, issues were identified with material receipt, equipment calibration intervals, and facility maintenance, indicating a need for improved quality systems.
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ID · b5b6a98b-9535-4ecf-a99b-1f3057cdae86