# FDA 483 - NOVAVAX CZ - July 18, 2023

Source: https://www.globalkeysolutions.net/records/483/novavax-cz/f987753e-ec7f-4b3c-b694-ecb5f68f2230

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Novavax CZ in Jevany, CZ, revealed significant deficiencies in data validation, process validation, and quality control. Observations included inadequate data to support validation reports, lack of data for potency determination, unvalidated holding times for process intermediates, and failed disinfectant efficacy studies. The firm also failed to implement timely corrective actions for recurring integrity failures and had deficient procedures for product handling.

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd