Alvotech Hf
Form 483 issued July 4, 2025 · Reykjavik, Iceland
- Inspection
- Jun 26 – Jul 4, 2025
- Investigators
- Della Shin· Ekaterina Allen· Hyung-Yul Lee
- Observations
- 10
- Pages
- 13
- FEI number
- 3013702557
In short: On July 4, 2025, FDA issued a Form 483 with 10 observations to Alvotech Hf in Reykjavik, Iceland (FEI 3013702557) after an inspection that ran Jun 26 – Jul 4, 2025. The investigators were Della Shin, Ekaterina Allen, Hyung-Yul Lee, Kathryn King, Leiyun Boone and Zhong Li. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 6 of 10 observations.
Most cited: 21 CFR 211.100 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
The responsibilities and procedures applicable to the quality unit…
- 03
There is a lack of assurance that your drug substance and drug product manufacturing operations are…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Della Shin
3 documents · 2024–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alvotech Hf?
FDA listed 10 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Alvotech Hf?
Della Shin, Ekaterina Allen, Hyung-Yul Lee, Kathryn King, Leiyun Boone and Zhong Li are named on this Form 483, for the inspection of Jun 26 – Jul 4, 2025. Each investigator has a profile showing what they cite most.
When was Alvotech Hf inspected by FDA?
The inspection ran Jun 26 – Jul 4, 2025, and the Form 483 is dated July 4, 2025.
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.