FDA 483 - LANXESS Corporation - September 12, 2024

During an inspection by the U.S. Food and Drug Administration (FDA) conducted from September 9-12, 2024, at LANXESS Corporation's facility in Kalama, WA, an observation was made regarding equipment maintenance. The inspection, targeting an Intermediate/Component Pharmaceutical Manufacturer, identified that equipment used in the production, processing, packaging, testing, or storage of an excipient was not maintained in a good state of repair. Specifically, FDA representatives observed product leakage from reactor tank R-921, which is utilized in the production of Sodium Benzoate NF/FCC Powder. This leakage was noted to have occurred since December 2021 and reoccurred in May 2023. The key issue highlighted was the absence of documented deviation records or investigations into these recurring leakages, implying production continued in equipment that was not in proper working order. This FDA 483 document serves as a notification of these inspectional observations. LANXESS Corporation is expected to address these findings by implementing documented corrective actions and investigations to resolve the identified equipment maintenance and quality system deficiencies, ensuring all manufacturing equipment adheres to regulatory standards for product quality and safety.