Alvotech Hf
Form 483 issued September 17, 2024 · Reykjavik, Iceland
- Inspection
- Sep 9 – Sep 17, 2024
- Observations
- 2
- Pages
- 3
- FEI number
- 3013702557
In short: On September 17, 2024, FDA issued a Form 483 with 2 observations to Alvotech Hf in Reykjavik, Iceland (FEI 3013702557) after an inspection that ran Sep 9 – Sep 17, 2024. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.192 (1×)
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 control unit are not fully followed. A. Your…
- 02
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
This inspection in context
Questions about this 483
What did FDA find at Alvotech Hf?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was Alvotech Hf inspected by FDA?
The inspection ran Sep 9 – Sep 17, 2024, and the Form 483 is dated September 17, 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.