FDA 483 - Fresenius Kabi USA LLC - September 01, 2015

Fresenius Kabi USA LLC in Melrose Park, IL, was inspected from August 17 to September 1, 2015. The inspection revealed a significant issue with the firm's packaging and labeling operations, specifically concerning the lack of independent verification for visual inspections of cut labels. This indicates a potential risk to product quality due to inadequate quality control procedures.