FDA 483 - Incyte Biosciences Technical Operations Sarl - February 11, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Inspection Date
- February 11, 2025
- Product Type
- Biologics
ID · 6d36eb88-4e1b-4b72-9252-b7ba3d1c2ad9