Celltrion Biosimilar Is Latest To Run Into GMP Compliance Concerns

 
• By Joanne S. Eglovitch

An FDA inspection uncovered a wide-ranging list of GMP problems at biopharmaceutical manufacturer Celltrion in South Korea. Among some of the problems that inspectors found were mold on walls in sterile areas, operators leaning over sterile areas with bare hands and arms, and employees using shared passwords. A resulting Form 483 report is the latest in a number of recent enforcement actions targeting proposed biosimilar drugs.

Celltrion Headquarters

FDA investigators found a multitude of GMP problems at Celltrion Inc. including lax contamination controls and inadequate investigation into complaints. This action is the latest of several GMP compliance challenges confronting manufacturers launching biosimilars in recent months.

Investigators sent a Form 483 report of inspectional observations June 2 after an inspection of the Incheon, South Korea, firm's manufacturing facility that began May 22

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