# FDA 483 - Alvotech HF - July 04, 2025

Source: https://www.globalkeysolutions.net/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)

## Related Documents

- [483 - 2024-01-19](https://www.globalkeysolutions.net/records/483/alvotech-hf/84d10df7-a051-47fa-a57d-a98a9fd53f28)
- [483 - 2023-03-17](https://www.globalkeysolutions.net/records/483/alvotech-hf/2fc5d0cc-3ce5-443d-b5bd-99cd014e8324)
- [483 - 2024-09-17](https://www.globalkeysolutions.net/records/483/alvotech-hf/6620ba68-5885-42f2-afe3-822bc7869868)
- [483 - 2025-07-04](https://www.globalkeysolutions.net/records/483/alvotech-hf/346dcec1-3c30-4a96-b754-25f338416aa0)
- [483 - 2022-03-17](https://www.globalkeysolutions.net/records/483/alvotech-hf/518df8cf-75de-43d3-8863-5196fb90687a)

## Related Officers

- [Zhong Li, Ph.D., Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/zhong-li-phd-senior-regulatory-specialist/8239f257-d22a-47ff-af8a-248ff122d717)
- [Delia Siro, PhD, Pharmaceutical Scientist](https://www.globalkeysolutions.net/people/delia-siro-phd-pharmaceutical-scientist/e11e58cc-ecd3-41d2-a426-8ea81d68220b)
- [Hyung-yul Lee, Ph.D, Pharmaceutical Scientist](https://www.globalkeysolutions.net/people/hyung-yul-lee-phd-pharmaceutical-scientist/fd263e12-7169-4dc7-a679-a57bdbeacd42)
- [Kathryn Miller, Microbiologist](https://www.globalkeysolutions.net/people/kathryn-miller-microbiologist/92fce77a-2053-4d75-be89-fd7bb7664e15)
- [Leiyun Boone, PhD, Lead Biologist](https://www.globalkeysolutions.net/people/leiyun-boone-phd-lead-biologist/bff36082-6e40-4d97-b452-8b89d415e5be)

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

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