FDA 483 - Fresenius Medical Care, North America - August 13, 2020

Fresenius Medical Care, North America in Ogden, UT, a sterile drug manufacturer, was cited for two observations during an FDA inspection. The firm failed to thoroughly investigate unexplained discrepancies related to rejected batches and lacked adequate written procedures for production and process controls. These deficiencies included issues with retaining critical alarm logs and controlling certificates of analysis.