Valneva Scotland Ltd. – FDA EIR, Mar 6, 2019

An FDA inspection of Sartorius Stedim BioOutsource, Ltd., a contract testing laboratory located in Glasgow, UK, was conducted from March 4-6, 2019. This Level 2 Good Manufacturing Practice (GMP) assessment, performed under FDA's Compliance Program 7345.848 for Biological Drug Products, evaluated the firm's operations related to the release and safety testing of a licensed biological product. Key violations identified primarily centered on deficiencies in laboratory control and quality systems. Significant issues included the absence of adequately defined test procedures for sterility testing of certain samples and final products, resulting in inconsistencies regarding sample quantity and volume. Additionally, sterility test methods for specific materials were implemented without proper qualification or documentation of method changes. Qualification studies for sterility testing were also found lacking essential elements such as clear protocols, objectives, test instructions, acceptance criteria, and comprehensive conclusions. Further observations included laboratory personnel's inability to access electronic testing procedures due to unformatted computers, and endotoxin testing forms missing critical instructions for sample preparation. The inspection also highlighted concerns regarding insufficient sample volumes for sterility testing and a failure to consistently review temperature data loggers for incoming samples. Following the inspection, an FDA-483, Inspectional Observations, was issued to site management, with the firm committing to provide written responses to all identified deficiencies.