Alvotech Hf
Form 483 issued March 17, 2022 · Reykjavík, Iceland
- Inspection
- Mar 10 – Mar 17, 2022
- Investigators
- Cynthia Jim· Madushini Dharmasena· Yetao Jin
- Observations
- 13
- Pages
- 10
- FEI number
- 3013702557
In short: On March 17, 2022, FDA issued a Form 483 with 13 observations to Alvotech Hf in Reykjavík, Iceland (FEI 3013702557) after an inspection that ran Mar 10 – Mar 17, 2022. The investigators were Cynthia Jim, Madushini Dharmasena and Yetao Jin. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and production account for 8 of 13 observations.
Most cited: 21 CFR 211.84 (4×) · 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The manufacturing areas are not under control for bacteria and mold. 1. There is an unacceptably…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alvotech Hf?
FDA listed 13 observations on this Form 483, mostly about materials, production and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Alvotech Hf?
Cynthia Jim, Madushini Dharmasena and Yetao Jin are named on this Form 483, for the inspection of Mar 10 – Mar 17, 2022. Each investigator has a profile showing what they cite most.
When was Alvotech Hf inspected by FDA?
The inspection ran Mar 10 – Mar 17, 2022, and the Form 483 is dated March 17, 2022.
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.