Alvotech HFJanuary 19, 2024

FDA 483 - Alvotech HF - January 19, 2024

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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.

Company: Alvotech HF
Inspection Date: January 19, 2024
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Ben Du
Scott C. Lute
Bingchen Du
Michael R. Shanks (Investigator)

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ID · e62442fa-f505-4bb5-a6c2-bbd0d5e04906