FDA EIR - Fresenius Kabi USA, LLC - March 30, 2017

An FDA inspection of Fresenius Kabi USA, LLC, located in Grand Island, NY, was conducted from March 21-30, 2017. This "for cause" high-priority inspection, requested by CDER, aimed to follow up on complaints of lack of efficacy, decreased effect, and thrombosis related to Heparin Sodium Injection. The inspection was conducted under FDA's Sterile Drug Process, Drug Quality Reporting System, and Postmarketing Adverse Drug Experience Reporting Compliance Programs. Key issues identified, leading to an FDA Form 483, included a persistent trend of out-of-specification bioburden results, primarily Ralstonia picketti, in the Formulation area since September 2013, with ineffective corrective measures and release of affected batches. The firm's stopper sterilization processes were found deficient, as the validation testing did not represent the maximum sterilizer load. Additionally, environmental monitoring in aseptic processing and filling lines was inadequate. This included bringing unsealed containers into critical areas, insufficient monitoring at critical junctures, and observed water on the floor in ISO5 areas during filling operations. While no direct link to Heparin efficacy issues was found, these observations require comprehensive corrective actions to ensure product quality and patient safety.