# FDA 483 - Alvotech HF - July 04, 2025

Source: https://www.keypedia.com/records/483/alvotech-hf/5079b423-9865-4022-80f6-6b2898a315bc

> FDA 483 for Alvotech HF on July 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alvotech HF
- Inspection Date: 2025-07-04
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Alvotech HF in Reykjavik, Iceland, a drug substance and drug product manufacturer, revealed significant deficiencies across its operations. The firm was cited for inadequate production and process controls, widespread failures in its quality unit, and a lack of robust contamination prevention measures. Additional concerns included poor aseptic processing, insufficient investigations into discrepancies, deficient laboratory controls, and compromised data integrity, indicating systemic issues in maintaining GMP compliance.

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## Related Officers

- [Zhong Li, Ph.D., Senior Regulatory Specialist](https://www.keypedia.com/people/zhong-li-phd-senior-regulatory-specialist/8239f257-d22a-47ff-af8a-248ff122d717)
- [Kathryn Miller, Microbiologist](https://www.keypedia.com/people/kathryn-miller-microbiologist/92fce77a-2053-4d75-be89-fd7bb7664e15)
- [Katarzyna M. Matusz, Pharmaceutical Scientist](https://www.keypedia.com/people/katarzyna-m-matusz-pharmaceutical-scientist/949b3890-ed49-4e4b-876c-c666aa0744b9)
- [Leiyun Boone, PhD, Lead Biologist](https://www.keypedia.com/people/leiyun-boone-phd-lead-biologist/bff36082-6e40-4d97-b452-8b89d415e5be)
- [Delia Siro, PhD, Pharmaceutical Scientist](https://www.keypedia.com/people/delia-siro-phd-pharmaceutical-scientist/e11e58cc-ecd3-41d2-a426-8ea81d68220b)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd