# FDA 483 - ImClone Systems, LLC - July 27, 2023

Source: https://www.keypedia.com/records/483/imclone-systems-llc/b5b6a98b-9535-4ecf-a99b-1f3057cdae86

> FDA 483 for ImClone Systems, LLC on July 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImClone Systems, LLC
- Inspection Date: 2023-07-27
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [483 - 2019-11-26](https://www.keypedia.com/records/483/imclone-systems-llc/ae1b1bac-061f-4570-b184-9b382ec3c67f)
- [483 - 2020-08-21](https://www.keypedia.com/records/483/imclone-systems-llc/db44c46a-32b3-4767-929a-56d701d813ae)
- [483 - 2023-07-27](https://www.keypedia.com/records/483/imclone-systems-llc/aca06d28-b62d-453e-a6cb-32610eccbc46)
- [483 - 2019-11-26](https://www.keypedia.com/records/483/imclone-systems-llc/47cd6878-6a5e-4876-9ce7-aee2c4c2cbc1)
- [EIR - 2015-07-10](https://www.keypedia.com/records/eir/imclone-systems-llc/783c5945-39b5-4aa5-a271-b36bbe7e834d)

## Related Officers

- [Samuel Mindaye, Lead Interdisciplinary Scientist](https://www.keypedia.com/people/samuel-mindaye-lead-interdisciplinary-scientist/2f50f059-06b1-49cf-a19f-05f7fec4e107)
- [Aditi Thakur, Chemist](https://www.keypedia.com/people/aditi-thakur-chemist/6792d738-798e-47da-b997-687b73087c63)
- [Leiyun Boone, PhD, Lead Biologist](https://www.keypedia.com/people/leiyun-boone-phd-lead-biologist/bff36082-6e40-4d97-b452-8b89d415e5be)
- [Charles Luan-Chia Kuo, Staff Fellow](https://www.keypedia.com/people/charles-luan-chia-kuo-staff-fellow/038269f6-aa8e-46f1-bb93-a5e1ae277d6e)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/imclone-systems-llc/ccde4edf-e0cb-4367-a935-725ce0bad4d3

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd