FDA 483 - Alvotech HF - July 04, 2025

An FDA inspection of Alvotech HF in Reykjavik, Iceland, a drug substance and drug product manufacturer, revealed significant deficiencies across its operations. The firm was cited for inadequate production and process controls, widespread failures in its quality unit, and a lack of robust contamination prevention measures. Additional concerns included poor aseptic processing, insufficient investigations into discrepancies, deficient laboratory controls, and compromised data integrity, indicating systemic issues in maintaining GMP compliance.