# FDA 483 - Alvotech HF - May 08, 2026

Source: https://www.keypedia.com/records/483/alvotech-hf/a79ae448-e34d-4221-bb51-71157dfded5a

> FDA 483 for Alvotech HF on May 08, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alvotech HF
- Inspection Date: 2026-05-08
- Product Type: biologics
- Office Name: FDA District Office — New England District Office, Massachusetts
- Summary: Alvotech HF, a biological drug substance and product manufacturer in Reykjavik, Iceland, was cited for significant deficiencies across five observations. The inspection revealed issues with complaint handling, aseptic process validation, laboratory controls for visual inspection, thoroughness of deviation investigations for microbiological contamination, and quality unit oversight of environmental monitoring trend reports. These findings indicate a moderate level of non-compliance with GMP regulations, particularly concerning quality systems and sterile manufacturing.

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## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/alvotech-hf/68dcb740-c89d-4dbc-934a-d8c7ccd414ab

Office: https://www.keypedia.com/offices/fda-district-office-new-england-district-office-massachusetts/158df8ca-ae0a-47d6-9fc6-f1c3dfe457cc