FDA EIR - Fresenius Kabi USA, LLC - April 14, 2015

An FDA inspection of Fresenius Kabi USA, LLC's analytical chemistry control testing laboratory, located on Cornell Avenue in Melrose Park, IL, was conducted from April 8 to April 14, 2015. This facility performs crucial analytical chemistry control testing for human sterile injectable drug products manufactured at their nearby Ruby Street site, in addition to warehousing components and distributing finished products. The inspection was conducted under Compliance Programs 7356.002, concerning "Drug Manufacturing Inspections," and 7356.002A, specifically for "Sterile Drug Process Inspections." The scope of this abbreviated inspection focused on the firm's Quality System and Laboratory Control Systems. Key areas reviewed included written procedures, cGMP investigations, change control, stability programs, and employee training for the Quality System, as well as analyst training, reference standard storage, adherence to methods, raw data review, and out-of-specification investigations for the Laboratory Controls System. Significantly, no main violations or issues were identified during this inspection. Consequently, the FDA did not issue a Form 483, 'Inspectional Observations,' nor were any items of concern communicated to the company's management at the conclusion of the inspection. As such, no specific required actions or voluntary corrections were necessitated from this inspection.