# FDA 483 - Valneva Scotland Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/valneva-scotland-ltd/749acd15-0e15-4373-89f9-47ea0bdae252

> FDA 483 for Valneva Scotland Ltd. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valneva Scotland Ltd.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Valneva Scotland Limited, a vaccine sterile bulk manufacturer in Livingston, Scotland, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into out-of-specification results and discrepancies, insufficient environmental controls in processing areas, and issues with product release without proper conformance determination. These findings indicate a need for improved quality system oversight and control.

## Related Documents

- [483 - 2018-04-24](https://www.globalkeysolutions.net/records/483/valneva-scotland-ltd/3ecac163-c60e-4d5c-802f-0358db7333a3)
- [EIR - 2019-03-06](https://www.globalkeysolutions.net/records/eir/valneva-scotland-ltd/6d6ca002-e964-40b1-954e-1eb13ca7fc5c)
- [483 - 2022-09-09](https://www.globalkeysolutions.net/records/483/valneva-scotland-ltd/d2a1278b-7fae-4fea-973b-3e9920d25ad4)
- [483 - 2024-03-05](https://www.globalkeysolutions.net/records/483/valneva-scotland-ltd/226a95a2-e671-4c11-bd54-7b0bcf0118c5)

## Related Officers

- [Dino Feigelstock, Ph. D., Research Biologist](https://www.globalkeysolutions.net/people/dino-feigelstock-ph-d-research-biologist/14bb815a-eda6-48ad-b6bf-d9d629c205e1)
- [Cynthia Jim](https://www.globalkeysolutions.net/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)
- [Gene Ancy, CSO](https://www.globalkeysolutions.net/people/gene-ancy-cso/9669dbe9-bc11-426f-940b-c9b70f94448e)

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

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