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483
•ImClone Systems, LLC•July 27, 2023

ImClone Systems, LLC – FDA 483, Jul 27, 2023

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.

Company
ImClone Systems, LLC
Inspection date
July 27, 2023
Product type
drugs
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People
  • Samuel Mindaye
  • Charles Luan-Chia Kuo, Staff Fellow
  • Wayne E. Seifert (Senior Regulatory Specialist)
  • Thuy T. Nguyen ( Investigator, Consumer Safety Officer)
  • Leiyun W. Boone (Lead Biologist)
View Company Profile

ID · b5b6a98b-9535-4ecf-a99b-1f3057cdae86

Other documents for ImClone Systems, LLC
  • 483 - 2022-08-22August 22, 2022
  • 483 - 2020-08-21August 21, 2020
  • 483 - 2019-11-26November 26, 2019
  • 483 - 2018-03-09March 9, 2018
  • EIR - 2017-09-21September 21, 2017

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