483
Alvotech HFAlvotech HF – FDA 483, Jan 19, 2024
Record Details
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.
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ID · e62442fa-f505-4bb5-a6c2-bbd0d5e04906
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