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

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