FDA 483 - Fresenius Kabi Compounding, LLC - November 05, 2025

Fresenius Kabi Compounding, LLC in Canton, MA, received a Form FDA 483 with seven observations during an inspection from October 9 to November 5, 2025. The inspection revealed significant deficiencies in quality control, aseptic processing, environmental monitoring, and facility maintenance, particularly concerning defective IV bag ports and procedures to prevent microbiological contamination. These issues indicate a lack of thorough investigation, inadequate adherence to sterile compounding procedures, and poor facility upkeep.