# FDA 483 - ImClone Systems, LLC - August 22, 2022

Source: https://www.keypedia.com/records/483/imclone-systems-llc/c62fe083-c70c-44f1-8d2f-aa5dfcaf28a3

> FDA 483 for ImClone Systems, LLC on August 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImClone Systems, LLC
- Inspection Date: 2022-08-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: ImClone Systems, LLC in Branchburg, NJ, a drug substance manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included failures to adequately control the disposition of drug substances during deviation investigations and to properly document and investigate deviations from established laboratory procedures. These issues indicate a lack of robust quality unit oversight and adherence to procedural controls.

## 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 - 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)
- [483 - 2020-08-21](https://www.keypedia.com/records/483/imclone-systems-llc/db44c46a-32b3-4767-929a-56d701d813ae)

## Related Officers

- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)
- [Kathleen M. Jordan](https://www.keypedia.com/people/kathleen-m-jordan/e08b786a-47bf-4e78-ae96-9d94cdc20bdb)

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