Celltrion’s Statement on Warning Letter Issued for its Drug Manufacturing Facility
On Jan. 30, 2018, Celltrion received a Warning Letter from the U.S. Food and Drug Administration (“FDA”) relating to an inspection FDA carried out from May 22 to June 2, 2017 at our drug manufacturing facility in Incheon, South Korea.
The letter raises issues related to certain manufacturing process at the facility. We are making progress addressing these concerns, and we are committed to working with the agency to fully resolve all outstanding issues with highest priority. Upon a careful review of the agency’s feedback outlined in the letter, we will provide a full response to the FDA within the next 15 days.
The warning letter does not affect Celltrion’s ability to manufacture and supply the INFLECTRA® (infliximab-dyyb) products from Incheon site, South Korea, and the Company does not currently anticipate any impact on the supply of INFLECTRA® (infliximab-dyyb) based on this warning letter. Celltrion remains confident in the safety and efficacy of its products manufactured at the site.