FDA 483 - Fresenius Kabi USA, LLC - October 24, 2014

Fresenius Kabi USA, LLC in Grand Island, NY, was inspected regarding its human sterile injectable pharmaceutical products. The inspection revealed significant deficiencies in quality control, including inadequate investigations into out-of-specification results and product integrity issues, and insufficient sampling schemes for incoming materials. Additionally, the facility's construction was found to be unsuitable for maintaining proper operations, with issues related to pest ingress and mold growth in manufacturing areas.