FDA 483 - Fresenius Medical Care, North America - March 06, 2026

An FDA inspection of Fresenius USA Manufacturing, Inc. in Ogden, UT, a sterilized drug manufacturer, revealed two significant observations. The firm's investigation records for batch failures, specifically regarding pinholes in primary bags, lacked complete conclusions and follow-up. Additionally, the company failed to establish adequate written procedures for production and process controls, particularly concerning the qualification of inspectors for routine 100% visual inspection of sterile drugs.