FDA 483 - Fresenius USA Manufacturing, Inc - June 22, 2020

Fresenius Medical Care North America in Knoxville, TN, a drug manufacturer, was cited for two significant issues during an FDA inspection. The firm failed to submit NDA-Field Alert Reports within three working days for multiple complaints of leaking drug product bags. Additionally, laboratory controls were found deficient as the firm's procedure for bacterial endotoxin assay did not require sample vials to be vortexed or mixed prior to testing.