Alvotech HF – FDA 483, Mar 17, 2022

The FDA inspection of Alvotech Hf in Reykjavik, Iceland, a drug substance and drug product manufacturer, revealed significant quality control and procedural deficiencies. Observations included inadequate qualification of incoming materials, uncontrolled manufacturing environments with high microbial counts, and improper classification of stopper defects. The firm also lacked adequate written procedures for various critical operations, indicating a need for comprehensive improvements in its quality management system.