Celltrion’s Statement on a recent form 483 from the U.S. FDA
2018.08.07
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.