trending Market Intelligence /marketintelligence/en/news-insights/trending/gtaadtjtonkadup9aqn-mg2 content esgSubNav
Log in to other products

 /


Looking for more?

Contact Us
In This List

South Korea's Celltrion gets US FDA warning over manufacturing plant

Blog

COVID-19 Impact & Recovery: Healthcare Outlook for H2 2021

Video

Climate Credit Analytics: Linking climate scenarios to financial impacts

Blog

Global M&A Infographic Q1 2021

Blog

Q1 2021 Global Capital Markets Activity: SPAC IPOs, Issuance in Consumer Discretionary Sector Surge


South Korea's Celltrion gets US FDA warning over manufacturing plant

Celltrion Inc. received a warning letter from the U.S. Food and Drug Administration for violations in its manufacturing plant.

The regulator cited a lack of written procedures, employee training and certain documentation, among others, at Celltrion's facility in Incheon, South Korea. The FDA listed eight observations from seven inspections of the site in July.

The company said it has provided a comprehensive response to address the FDA's concerns and expects the outstanding observations to be lifted shortly.

In January, Celltrion also received a warning letter for issues at its Incheon facility. In April, the FDA rejected the company's application to gain marketing approval for two biosimilar drugs, citing that warning letter.