FDA 483 - Valneva Scotland Ltd. - April 16, 2018

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.