# FDA 483 - Alvotech HF - January 19, 2024

Source: https://www.keypedia.com/records/483/alvotech-hf/e62442fa-f505-4bb5-a6c2-bbd0d5e04906

> FDA 483 for Alvotech HF on January 19, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Alvotech HF
- Inspection Date: 2024-01-19
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [483 - 2024-01-19](https://www.keypedia.com/records/483/alvotech-hf/84d10df7-a051-47fa-a57d-a98a9fd53f28)
- [483 - 2025-07-04](https://www.keypedia.com/records/483/alvotech-hf/5079b423-9865-4022-80f6-6b2898a315bc)
- [483 - 2024-09-17](https://www.keypedia.com/records/483/alvotech-hf/6620ba68-5885-42f2-afe3-822bc7869868)
- [483 - 2025-07-04](https://www.keypedia.com/records/483/alvotech-hf/824328c1-c31f-42b1-aab9-c3c870d14b90)
- [483 - 2024-09-17](https://www.keypedia.com/records/483/alvotech-hf/f90f1473-0064-43a6-b6c6-dd5307e66091)

## Related Officers

- [Scott C. Lute](https://www.keypedia.com/people/scott-c-lute/20620306-e1c7-42b1-9545-7da1801d350f)
- [Ben Du](https://www.keypedia.com/people/ben-du/2bd46e1e-9e53-499f-be77-f006b789bb98)
- [Bingchen Du](https://www.keypedia.com/people/bingchen-du/2df8f706-844c-46b1-8461-51f0b9f0585b)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.keypedia.com/companies/alvotech-hf/68dcb740-c89d-4dbc-934a-d8c7ccd414ab

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd