FDA 483 - Incyte Biosciences Technical Operations Sarl - February 11, 2025

An FDA Form 483 was issued to Incyte Biosciences Technical Operation S.a.r.l., a drug substance manufacturer in Yverdon Les Bains, Switzerland, following an inspection. The inspection revealed significant deficiencies in quality control procedures, including inadequate drug substance identity and purity testing, insufficient deviation investigations, and poorly defined manufacturing work instructions. Additionally, issues were noted with endotoxin method verification and the demonstration of microbial control for both in-process hold times and post-storage drug substance.