Atlas

FDA-Inspected Site

Alvotech HF

6 FDA inspections are on record for Alvotech HF in Reykjavik, Iceland.

483· Form 483 issued

Reykjavik, Iceland · Last updated July 11, 2026

Overview

  • 6 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-08.

At a glance

Inspections

6

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
29 Apr 2026 – 8 May 2026Human Drugs483On file
26 Jun 2025 – 4 Jul 2025Human Drugs483On file
9 Sep 2024 – 17 Sep 2024Human Drugs483On file
10 Jan 2024 – 19 Jan 2024Human Drugs483On file
6 Mar 2023 – 17 Mar 2023Human Drugs483On file
10 Mar 2022 – 17 Mar 2022Human Drugs483On file

Investigators

FDA investigators tied to this site in the record.

Matthew B Casale1 insp.
Saleem A Akhtar1 insp.
Zhong Li1 insp.
Ekaterina Allen1 insp.
Kathryn E King1 insp.
Hyung-Yul Lee1 insp.
Della Shin1 insp.
Leiyun W Boone1 insp.
Jose E Melendez1 insp.
Michael Shanks1 insp.
Scott C Lute1 insp.
Bingchen Du1 insp.
Arsen Karapetyan1 insp.
Richard Ledwidge1 insp.
Lei Zhang1 insp.
Cynthia Jim1 insp.
Madushini N Dharmasena1 insp.

Full site report

Get the verbatim findings behind Alvotech HF's 6 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat