Fresenius Kabi USA, LLC – FDA EIR, Dec 17, 2013

An FDA inspection of Fresenius Kabi USA, LLC's Melrose Park, IL chemistry control testing lab and warehouse for human sterile injectable drug products was conducted from September 26 to December 17, 2013. The inspection, assigned as an FY14 Performance Goal, focused on the firm's Quality and Laboratory systems under Compliance Programs 7356.002 and 7356.002A, pertaining to drug manufacturing and sterile drug processes, respectively. During this comprehensive review, the investigators found nothing objectionable and issued no FDA-483 form, indicating a satisfactory compliance status. Furthermore, no specific concerns were discussed with company management at the conclusion of the inspection. The report also noted that previous discussion items from an earlier inspection in November 2012, which included concerns regarding facility registration, logging of chromatography system suitability failures, and clarity in temperature and humidity excursion records, were verified as corrected by the firm prior to or during the current inspection. Additionally, corrective actions for sample handling discussions related to Heparin Lock Flush Solution testing at a former alternative site were also verified. No new regulatory actions were required as a result of this inspection.