FDA 483 - Alvotech HF - July 04, 2025

Alvotech HF, a drug substance and drug product manufacturer in Reykjavik, Iceland, was inspected and found to have significant deficiencies across its operations. Key issues include inadequate production and process controls, failures in quality unit oversight, widespread microbial contamination risks in manufacturing environments, and poor aseptic processing. Additionally, the firm demonstrated a lack of thorough investigations for discrepancies, insufficient laboratory controls, deficient documentation practices, and inadequate control over electronic data and service contractors.