trending Market Intelligence /marketintelligence/en/news-insights/trending/gtaadtjtonkadup9aqn-mg2 content esgSubNav
In This List

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

Blog

Insight Weekly: Ukraine war impact on mining; US bank growth slowdown; cloud computing headwinds

Blog

Insight Weekly: Cryptocurrency's growth; green bond market outlook; coal investors' windfall

Blog

Global M&A By the Numbers: Q1 2022

Blog

Insight Weekly: Challenges for European banks; Japan's IPO slowdown; carmakers' supply woes


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.