# FDA 483 - NOVAVAX CZ - July 18, 2023

Source: https://www.keypedia.com/records/483/novavax-cz/1668d6f9-f977-4cb2-a62e-288ccf956782

> FDA 483 for NOVAVAX CZ on July 18, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NOVAVAX CZ
- Inspection Date: 2023-07-18
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: An FDA inspection of Novavax CZ in Jevany, CZ, revealed several significant deficiencies in their manufacturing processes. Observations included inadequate data in validation reports, lack of support for reference standards, and unvalidated holding times for process intermediates. The firm also faced issues with disinfectant efficacy studies, untimely corrective actions for recurring integrity failures, and deficient product handling procedures.

## Related Documents

- [483 - 2023-07-18](https://www.keypedia.com/records/483/novavax-cz/f987753e-ec7f-4b3c-b694-ecb5f68f2230)

## Related Officers

- [Pankaj H. Amin](https://www.keypedia.com/people/pankaj-h-amin/c67bcc04-9aa5-4c13-b389-29d25513188e)

Company: https://www.keypedia.com/companies/novavax-cz/946f94c6-3077-4879-8af9-0f52bccf0bd5

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d