# FDA 483 - Alvotech HF - March 17, 2023

Source: https://www.keypedia.com/records/483/alvotech-hf/b6f28059-74e7-41bf-be00-b56ed5678c44

> FDA 483 for Alvotech HF on March 17, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alvotech HF
- Inspection Date: 2023-03-17
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 was issued to Alvotech Hf, a Drug Substance and Drug Product Manufacturer located in Reykjavik, Iceland, following an inspection from March 6-17, 2023. The report identifies eight observations regarding deficiencies in their quality system and manufacturing practices.

**Key Observations:**

1.  **Inadequate Quality Unit Responsibilities and Procedures:** The Quality Unit (QU) failed to ensure drug products were manufactured according to cGMP. This includes issues with laboratory data review, investigations, and adherence to written procedures. Examples include:
    *   Quality Assurance (QA) approving Process Performance Qualification (PPQ) despite out-of-trend results for drug substance batches leading to out-of-specification (OOS) drug product batches.
    *   QA approving PPQ reports where specified drug substance batches were not used in drug product PPQ.
    *   QA approving a change control allowing secondary packaging and labeling before drug substance release, with plans to continue this practice.
    *   Deficient supervisory oversight over quality/production unit operations and laboratory electronic systems/data, including "Data Incomplete" and "Bad Checksum" chromatography data not being adequately investigated, unrestricted access to original electronic test data, and inadequate review of all generated electronic test data.
    *   Failure to follow established QU procedures, such as not completing a trend report and user access/system audit trail reviews.
    *   Failure to

## Related Documents

- [483 - 2022-03-17](https://www.keypedia.com/records/483/alvotech-hf/f8b2cdd6-4e1e-4f71-ab0c-260041ebe020)
- [483 - 2022-03-17](https://www.keypedia.com/records/483/alvotech-hf/57656c63-6d7f-4bfd-af74-e50923bfd21c)
- [483 - 2023-03-17](https://www.keypedia.com/records/483/alvotech-hf/e28e29f5-54c9-4f3e-8f7a-bee8fa309e2e)
- [483 - 2024-01-19](https://www.keypedia.com/records/483/alvotech-hf/e62442fa-f505-4bb5-a6c2-bbd0d5e04906)
- [483 - 2024-01-19](https://www.keypedia.com/records/483/alvotech-hf/84d10df7-a051-47fa-a57d-a98a9fd53f28)

## Related Officers

- [Richard Ledwidge](https://www.keypedia.com/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)
- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Lei Zhang](https://www.keypedia.com/people/lei-zhang/4cb14112-7090-4e62-b308-a1bc41cd6fcf)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c