# FDA 483 - Valneva Scotland Ltd. - March 05, 2024

Source: https://www.keypedia.com/records/483/valneva-scotland-ltd/226a95a2-e671-4c11-bd54-7b0bcf0118c5

> FDA 483 for Valneva Scotland Ltd. on March 05, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valneva Scotland Ltd.
- Inspection Date: 2024-03-05
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of Valneva Scotland Ltd. in Livingston, United Kingdom, revealed significant deficiencies in their biologics/vaccine manufacturing operations. Observations included inadequate environmental monitoring in aseptic processing areas, a quality control unit failing to timely close deviations and manage change requests, and deficient procedures for handling product complaints. Additionally, issues were noted with the drug substance sampling strategy for mycobacteria testing and batch record documentation.

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## Related Officers

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Company: https://www.keypedia.com/companies/valneva-scotland-ltd/7e6970c2-c9dd-4c5d-9d35-725121b6e877

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321