FDA 483 - Fresenius Kabi Compounding, LLC - December 04, 2018

An FDA inspection of Fresenius Kabi Compounding, LLC in Canton, MA, an outsourcing facility, revealed significant deficiencies in their manufacturing of sterile drug products, particularly potassium chloride injection USP. The firm failed to adequately investigate sterility test failures and discrepancies, maintain proper aseptic processing controls, and ensure the integrity of their quality control unit. Additionally, issues were noted with environmental monitoring, cleaning procedures, visual inspection processes, container closure integrity, and product labeling.