Alvotech Hf
Form 483 issued March 17, 2023 · Reykjavik, Iceland
- Inspection
- Mar 6 – Mar 17, 2023
- Investigators
- Arsen Karapetyan· Lei Zhang· Richard Ledwidge
- Observations
- 8
- Pages
- 12
- FEI number
- 3013702557
In short: On March 17, 2023, FDA issued a Form 483 with 8 observations to Alvotech Hf in Reykjavik, Iceland (FEI 3013702557) after an inspection that ran Mar 6 – Mar 17, 2023. The investigators were Arsen Karapetyan, Lei Zhang and Richard Ledwidge. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality unit are not in…
- 02
Written records of OOS and deviation investigations do not always include the conclusions and follow- up…
- 03
Quality of incoming stoppers…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in quality…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alvotech Hf?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Alvotech Hf?
Arsen Karapetyan, Lei Zhang and Richard Ledwidge are named on this Form 483, for the inspection of Mar 6 – Mar 17, 2023. Each investigator has a profile showing what they cite most.
When was Alvotech Hf inspected by FDA?
The inspection ran Mar 6 – Mar 17, 2023, and the Form 483 is dated March 17, 2023.
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.