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[Notice to shareholders] 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.

 

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