# Alvotech HF – FDA 483, Mar 17, 2023

Source: https://www.keypedia.com/records/483/alvotech-hf/e28e29f5-54c9-4f3e-8f7a-bee8fa309e2e

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- 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

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## Related Officers

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

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