Alvotech Hf
FDA inspection history across 2 sites, 2022 to 2026
- 6
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2023: one Form 483; 2024: two Form 483s; 2025: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–26Six Form 483s, at Reykjavík, Iceland and Reykjavik, Iceland.
- 2022The longest 483 on file: 13 observations over 10 pages at Reykjavík, Iceland.
Cited most
Across all Alvotech Hf observations on file
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.192Production record review6
- 21 CFR 211.160General requirements5
- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures5
The complete Alvotech Hf file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Reykjavik, Iceland
Five Form 483s · 2023 to 2026 · 26 observations
Latest: Form 483, May 8, 2026 →Reykjavík, Iceland
One Form 483 · 2022 · 13 observations
Latest: Form 483, Mar 17, 2022 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-08 | 483 Form 483 | Reykjavik, Iceland | 5 | $99 |
| 2025-07-04 | 483 Form 483 | Reykjavik, Iceland | 10 | $99 |
| 2024-09-17 | 483 Form 483 | Reykjavik, Iceland | 2 | $99 |
| 2024-01-19 | 483 Form 483 | Reykjavik, Iceland | 1 | $99 |
| 2023-03-17 | 483 Form 483 | Reykjavik, Iceland | 8 | $99 |
| 2022-03-17 | 483 Form 483 | Reykjavík, Iceland | 13 | $99 |
Investigators on these documents
Arsen Karapetyan (1)Bingchen Du (1)Cynthia Jim (1)Della Shin (1)Ekaterina Allen (1)Hyung-Yul Lee (1)Kathryn King (1)Lei Zhang (1)Leiyun Boone (1)Madushini Dharmasena (1)Matthew B. Casale (1)Michael R. Shanks (1)
FEI number 3013702557 · most recent document May 8, 2026
About Alvotech Hf
How many FDA Form 483s has Alvotech Hf received?
FDA Intel has 6 Form 483s on file for Alvotech Hf; the most recent is dated May 8, 2026.
When was Alvotech Hf last inspected by FDA?
The most recent FDA inspection document on file for Alvotech Hf is a Form 483 dated May 8, 2026, for the site in Reykjavik, Iceland.
What did FDA cite at Alvotech Hf?
The regulations cited most in the observations on file for Alvotech Hf are 21 CFR 211.113 (Control of microbiological contamination), 8 times; 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.160 (General requirements), 5 times.