# FDA 483 - ImClone Systems, LLC - August 21, 2020

Source: https://www.keypedia.com/records/483/imclone-systems-llc/db44c46a-32b3-4767-929a-56d701d813ae

> FDA 483 for ImClone Systems, LLC on August 21, 2020. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ImClone Systems, LLC
- Inspection Date: 2020-08-21
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: ImClone Systems, L.L.C. in Branchburg, NJ, a biological drug substance manufacturer, was cited for significant quality system and laboratory control deficiencies. The firm failed to thoroughly investigate unexplained discrepancies and batch failures, often misclassifying serious GMP violations as minor observations. Additionally, laboratory controls lacked scientifically sound and consistent test procedures for drug substances, leading to uncontrolled and irreproducible purity method results.

## Related Documents

- [483 - 2019-11-26](https://www.keypedia.com/records/483/imclone-systems-llc/47cd6878-6a5e-4876-9ce7-aee2c4c2cbc1)
- [483 - 2020-08-21](https://www.keypedia.com/records/483/imclone-systems-llc/17887304-654e-4236-96ff-77b26cdf4296)
- [483 - 2022-08-22](https://www.keypedia.com/records/483/imclone-systems-llc/c62fe083-c70c-44f1-8d2f-aa5dfcaf28a3)
- [483 - 2019-11-26](https://www.keypedia.com/records/483/imclone-systems-llc/ae1b1bac-061f-4570-b184-9b382ec3c67f)
- [483 - 2022-08-25](https://www.keypedia.com/records/483/imclone-systems-llc/bb047a85-d942-468f-ba8c-12d4c36b0558)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ko-min/767a6604-9a34-49c7-8462-c763c2689f61)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248