FDA 483 - SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals) - March 15, 2024

An FDA inspection conducted at SmithKline Beecham Pharma GmbH & co. KG, operating as GlaxoSmithKline Biologicals, in Dresden, Germany, from March 8 to March 15, 2024, resulted in the issuance of a Form FDA 483. This document outlines observations made during the inspection, which are not a final determination of compliance but highlight areas requiring attention for this licensed biological drug product manufacturer.The primary observation noted a deficiency in laboratory controls, specifically the absence of scientifically sound and appropriate test procedures to ensure the identity, strength, quality, and purity of in-process materials and drug products. This was evidenced by two key issues. Firstly, standards and samples for Sodium deoxycholate content analysis in Fluarix vaccine were not consistently integrated, affecting approximately 40 batches between June and December 2023, some of which were released. Secondly, a test for Triton X-100 in Fluarix monovalent bulk was invalidated due to a suspected "dilution error" without a formal investigation, leading the analyst to proceed with re-prepared samples. The batch in question had already been released.These observations indicate that the firm needs to review and enhance its laboratory control procedures and investigation processes. The company is expected to respond to the FDA with a plan addressing these inspectional observations to ensure ongoing compliance.