# FDA 483 - ImClone Systems, LLC - August 25, 2022

Source: https://www.keypedia.com/records/483/imclone-systems-llc/bb047a85-d942-468f-ba8c-12d4c36b0558

> FDA 483 for ImClone Systems, LLC on August 25, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImClone Systems, LLC
- Inspection Date: 2022-08-25
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of ImClone Systems, LLC, a drug substance manufacturer located at 33 ImClone Drive, Branchburg, NJ 08876, was conducted on 07/26-29/2022, 08/02-05/2022, and 08/22-25/2022. The inspection, issued to Nellie D. Clark, VP, Site Head of Manufacturing, identified two observations.

Observation 1 noted a failure to control the disposition and availability of drug substances within the scope of deviation investigations before satisfactory quality unit evaluation. Specifically, drug substance lots implicated in Deviation Investigation TR# (b)(4) (initiated 06/25/2022 for unknown debris in a production CIP tank) were not adequately controlled. Additionally, not all implicated drug substance lots, such as Material Number: (b)(4) Dulaglutide (b)(4) Drug Substance, Batch: (b)(4), were included in the initial deviation record (b)(4) populated on 06/28-29/2022. The closed deviation record (TR# (b)(4), 07/25/2022) also omitted several implicated drug substances, including Olaratumab (IMC-3G3), Ramucirumab, and Necitumumab.

Observation 2 cited

## 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 - 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