FDA 483 - Alvotech HF - May 08, 2026

Alvotech HF, a biological drug substance and product manufacturer in Reykjavik, Iceland, was cited for significant deficiencies across five observations. The inspection revealed issues with complaint handling, aseptic process validation, laboratory controls for visual inspection, thoroughness of deviation investigations for microbiological contamination, and quality unit oversight of environmental monitoring trend reports. These findings indicate a moderate level of non-compliance with GMP regulations, particularly concerning quality systems and sterile manufacturing.