FDA 483 - Alvotech HF - January 19, 2024

Alvotech Hf in Reykjavik, Iceland, was issued a Form 483 following an inspection from January 10-19, 2024. The inspection identified an inadequacy in the firm's environmental and personnel monitoring for a RABS filling line. This included concerns about frequent operator sanitization during critical interventions potentially impacting microbial data and incomplete monitoring of RABS locations.