Celltrion’s Statement on a recent form 483 from the U.S. FDA


Celltrion confirms that in July 17, The U.S. Food and Drug Administration (FDA) completed its re-inspection of Celltrion’s Incheon, Korean manufacturing site.

After the re-inspection, FDA issued a Form 483 with 8 manageable and correctible inspection observations.

Celltrion provided comprehensive response ahead of schedule to the agency to address the observations.

Celltrion awaits the outcome of the recent re-inspection and expects outstanding observations will be lifted very soon.

Celltrion is committed to working with the agency to gain approval of CT-P10 and CT-P6 by the end of this year.