# FDA 483 - ImClone Systems, LLC - March 09, 2018

Source: https://www.keypedia.com/records/483/imclone-systems-llc/15bc1098-5ad2-4372-9bdf-209468afb7a5

> FDA 483 for ImClone Systems, LLC on March 09, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImClone Systems, LLC
- Inspection Date: 2018-03-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of ImClone Systems, LLC. d.b.a. Eli Lilly and Company in Branchburg, NJ, identified deficiencies in aseptic processing areas. The firm failed to conduct proper smoke studies for ISO 5 Bio Safety Cabinets and did not perform adequate media fills to simulate aseptic production operations, indicating issues with environmental monitoring and contamination prevention procedures.

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## Related Officers

- [Yvesna Blaise](https://www.keypedia.com/people/yvesna-blaise/4cd6b7c2-78a7-490d-9354-52046bc7344f)
- [Jose Hernandez-Guzman](https://www.keypedia.com/people/jose-hernandez-guzman/5e522aa9-a613-408f-b360-74c0fe4d8b30)
- [recipient](https://www.keypedia.com/people/yan-wang/9152655d-5458-4869-8e15-3227cec56699)
- [Nailing Zhang](https://www.keypedia.com/people/nailing-zhang/d3814d08-b799-4de1-b901-1b90da0e0178)

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