FDA EIR - Valneva Scotland Ltd. - April 24, 2018

Valneva Scotland Limited underwent an FDA inspection from April 16-24, 2018, under the FY18 Team Biologics work plan and Compliance Program 7345.848. The company manufactures sterile, formulated, purified, and inactivated Japanese Encephalitis Virus bulk vaccine. The inspection verified that all objectionable conditions documented during a previous 2016 inspection had been corrected.

However, the current inspection identified new issues, resulting in a FORM FDA 483. Main violations included a failure to thoroughly review unexplained discrepancies such as Out-of-Specification (OOS) results, particulate matter in samples, and equipment failures. Corresponding written investigation records were also found to be inadequate. The firm released drug product for distribution without ensuring conformance to final specifications, specifically due to using unqualified alternative sample containers for testing. Furthermore, environmental controls in processing areas exhibited deficiencies regarding temperature, humidity, and pressure differential. An environmental monitoring probe was improperly positioned near aseptic operations, and certain equipment restarts lacked formal documentation or justification. Valneva management was instructed to provide a written response to the FDA detailing the corrective actions taken.