Alvotech Hf
Form 483 issued May 8, 2026 · Reykjavik, Iceland
- Inspection
- Apr 29 – May 8, 2026
- Investigators
- Matthew B. Casale· Saleem A. Akhtar
- Observations
- 5
- Pages
- 7
- FEI number
- 3013702557
In short: On May 8, 2026, FDA issued a Form 483 with 5 observations to Alvotech Hf in Reykjavik, Iceland (FEI 3013702557) after an inspection that ran Apr 29 – May 8, 2026. The investigators were Matthew B. Casale and Saleem A. Akhtar. Most observations concern quality system and production.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmAlvotech Hf history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alvotech Hf?
FDA listed 5 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Alvotech Hf?
Matthew B. Casale and Saleem A. Akhtar are named on this Form 483, for the inspection of Apr 29 – May 8, 2026. Each investigator has a profile showing what they cite most.
When was Alvotech Hf inspected by FDA?
The inspection ran Apr 29 – May 8, 2026, and the Form 483 is dated May 8, 2026.
How do I get the full Form 483 for Alvotech Hf?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.