FDA 483 - HP Halden Pharma AS - May 10, 2023

Between May 2 and May 10, 2023, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Fresenius Kabi Norge As manufacturing facility located in Halden, Norway. The inspection identified several significant deficiencies across the company’s quality, production, and material systems. Key violations included a recurring failure to thoroughly investigate manufacturing discrepancies and customer complaints. Specifically, investigators noted that many internal reports lacked root cause analyses, delayed the documentation of errors, and failed to establish preventive actions for equipment failures. Furthermore, the firm’s production controls were found inadequate; cleaning validations for manufacturing equipment were outdated, with some data originating from 2010, and failed to address recent test deviations. The FDA also highlighted risks regarding material contamination, such as the use of unsanitary machinery in clean sampling areas and uncovered warehouse lighting. Finally, the facility failed to maintain required storage temperatures for specific drug products, potentially compromising their integrity. Under the FDA’s regulatory framework for pharmaceutical manufacturing, these observations require the company to provide a formal response. Fresenius Kabi must outline corrective actions taken or planned to address these issues and ensure future compliance with safety and quality standards.