Alvotech Hf — FDA Facility Profile
Alvotech Hf is an FDA-registered facility (FEI 3013702557) located in Iceland (ISL). Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 8, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Form 483 and inspection documents
- 6 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 8, 2026 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 17, 2024 | Voluntary Action Indicated (VAI) | No citations listed |
Form 483s and inspection documents
- May 8, 2026: 483 on FDA.gov
- Jul 4, 2025: 483 on FDA.gov
- Sep 17, 2024: 483 on FDA.gov
- Jan 19, 2024: 483 on FDA.gov
- Mar 17, 2023: 483 on FDA.gov
- Mar 17, 2022: 483 on FDA.gov
Facility details
- Company
- Alvotech HF
- Location
- Iceland (ISL)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
- Source
- decrs