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# ImClone Systems FDA-483
- URL: https://www.fdaweb.com/imclone-systems-fda-483/
- Published: 2022-10-20T12:00:00.000Z
- Updated: 2026-09-14T18:03:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153016

FDA has released the form [FDA-483](https://www.fda.gov/media/162405/download?ref=fdaweb.com) with two observations from a 7/26-8/5 inspection at ImClone Systems, Branchburg, NJ, a drug substance manufacturer. The inspection observations were:

- failing to control the disposition and availability of drug substances determined to be within the scope of deviation investigations before the satisfactory completion of evaluation by the quality unit; and
- failing to adequately document, explain, and investigate all deviations from established laboratory procedures.