# FDA 483 - Alvotech HF - September 17, 2024

Source: https://www.keypedia.com/records/483/alvotech-hf/f90f1473-0064-43a6-b6c6-dd5307e66091

> FDA 483 for Alvotech HF on September 17, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alvotech HF
- Inspection Date: 2024-09-17
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: Alvotech HF in Reykjavik, Iceland, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to ensure distributed drug products met quality standards, inadequately investigated complaints, and did not report a critical product defect. Additionally, the firm did not thoroughly investigate numerous out-of-specification endotoxin test results, lacking proper justification and corrective actions.

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- [483 - 2022-03-17](https://www.keypedia.com/records/483/alvotech-hf/f8b2cdd6-4e1e-4f71-ab0c-260041ebe020)

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8