# FDA 483 - ImClone Systems, LLC - November 26, 2019

Source: https://www.globalkeysolutions.net/records/483/imclone-systems-llc/ae1b1bac-061f-4570-b184-9b382ec3c67f

> FDA 483 for ImClone Systems, LLC on November 26, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImClone Systems, LLC
- Inspection Date: 2019-11-26
- 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 data integrity issues during an FDA inspection. The firm failed to exercise appropriate controls over computer systems in both its manufacturing production and Quality Control laboratory environments. These deficiencies included deleted audit trails, unreviewed data, and inadequate access controls, indicating a serious lack of oversight for critical data used in producing drug substances distributed in the U.S. market.

## Related Documents

- [483 - 2019-11-26](https://www.globalkeysolutions.net/records/483/imclone-systems-llc/47cd6878-6a5e-4876-9ce7-aee2c4c2cbc1)
- [483 - 2020-08-21](https://www.globalkeysolutions.net/records/483/imclone-systems-llc/17887304-654e-4236-96ff-77b26cdf4296)
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- [483 - 2022-08-22](https://www.globalkeysolutions.net/records/483/imclone-systems-llc/c62fe083-c70c-44f1-8d2f-aa5dfcaf28a3)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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

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