Alvotech Hf
Form 483 issued January 19, 2024 · Reykjavik, Iceland
- Inspection
- Jan 10 – Jan 19, 2024
- Investigators
- Bingchen Du· Michael R. Shanks· Scott C. Lute
- Observations
- 1
- Pages
- 1
- FEI number
- 3013702557
In short: On January 19, 2024, FDA issued a Form 483 with 1 observation to Alvotech Hf in Reykjavik, Iceland (FEI 3013702557) after an inspection that ran Jan 10 – Jan 19, 2024. The investigators were Bingchen Du, Michael R. Shanks and Scott C. Lute. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your environmental/personnel monitoring for Building RABS Filling Line…
This inspection in context
Bingchen Du
2 documents · 2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Germany.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alvotech Hf?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Alvotech Hf?
Bingchen Du, Michael R. Shanks and Scott C. Lute are named on this Form 483, for the inspection of Jan 10 – Jan 19, 2024. Each investigator has a profile showing what they cite most.
When was Alvotech Hf inspected by FDA?
The inspection ran Jan 10 – Jan 19, 2024, and the Form 483 is dated January 19, 2024.
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.