FDA 483 - Alvotech HF - September 17, 2024

Alvotech HF in Reykjavik, Iceland, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to ensure distributed drug products met quality standards, inadequately investigated complaints, and did not report a critical product defect. Additionally, the firm did not thoroughly investigate numerous out-of-specification endotoxin test results, lacking proper justification and corrective actions.