# FDA 483 - Alvotech HF - March 17, 2022

Source: https://www.keypedia.com/records/483/alvotech-hf/57656c63-6d7f-4bfd-af74-e50923bfd21c

> FDA 483 for Alvotech HF on March 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alvotech HF
- Inspection Date: 2022-03-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The FDA inspection of Alvotech Hf in Reykjavik, Iceland, a drug substance and drug product manufacturer, revealed significant quality control and procedural deficiencies. Observations included inadequate qualification of incoming materials, uncontrolled manufacturing environments with high microbial counts, and improper classification of stopper defects. The firm also lacked adequate written procedures for various critical operations, indicating a need for comprehensive improvements in its quality management system.

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## Related Officers

- [Cynthia Jin, Consumer Safety Officer](https://www.keypedia.com/people/cynthia-jin-consumer-safety-officer/2b26267f-a490-4d73-8adc-445370528b2a)
- [Madushini Dharmasena, Ph.D., Senior Pharmaceutical Quality Assessor](https://www.keypedia.com/people/madushini-dharmasena-phd-senior-pharmaceutical-quality-assessor/c2889164-8138-4129-a531-fdabde8d1b4b)
- [Yetao Liu, Ph.D., Chemist](https://www.keypedia.com/people/yetao-liu-phd-chemist/df8465a3-bd34-4bee-898d-132209a04c18)

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