FDA EIR - Fresenius Kabi USA, LLC - October 24, 2014

The FDA conducted a Good Manufacturing Practice (GMP) inspection of Fresenius Kabi USA, LLC in Grand Island, NY, from October 20-24, 2014. This was a for-cause inspection under regulatory frameworks like CPGM 7356.002A for sterile drug processes, serving as a follow-up to a February 2012 Warning Letter and an eight-item FDA-483 issued during a previous January 2013 inspection, which cited repeated violations and new deficiencies. While the firm had made significant progress in addressing prior issues, the current inspection resulted in an FDA-483 with three specific observations. Main violations included the failure to thoroughly review laboratory out-of-specification results, an inadequate incoming glass vial sampling scheme, and building design/construction flaws that allowed insect ingress and mold growth. Verbal observations highlighted inconsistent aseptic techniques, inadequate time stamps on GMP documents, and deficiencies in water sample analysis and equipment qualifications. Fresenius Kabi USA, LLC was required to submit a written response to both the FDA-483 and verbal observations within fifteen business days, with the effectiveness of corrective actions to be verified in subsequent routine inspections.