483
Valneva Scotland Ltd.FDA 483 - Valneva Scotland Ltd.
Record Details
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.
- Company
- Valneva Scotland Ltd.
- Product Type
- Biologics
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ID · 749acd15-0e15-4373-89f9-47ea0bdae252