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FDA Warning Letter Calls Attention to Celltrion's 'Poor' Aseptic Practices

 
• By Joanne S. Eglovitch

FDA warning letter to South Korean manufacturer Celltrion cites an extensive list of problems related to inadequate contamination controls and shows how companies launching biosimilars can be tripped up by GMP compliance problems.

Celltrion plant google street view no 2
Celltrion's Incheon plant • Source: Google street view

An FDA warning letter issued on Jan. 26 to Celltrion Inc. in Incheon, South Korea cited an extensive number of GMP violations with a good number of these problems stemming from lax contamination controls.

Since the summer, there has been a spate of drug GMP warning letters going to foreign drug manufacturers and particularly to firms in Asia

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