FDA 483 - Fresenius Kabi USA, LLC - August 12, 2019

Fresenius Kabi USA, LLC, a sterile drug manufacturer in Grand Island, NY, received a Form 483 with two observations. The firm failed to establish adequate control procedures for manufacturing processes, specifically regarding the evaluation of decontamination effects on drug product compatibility. Additionally, the quality control unit did not perform timely reviews of analytical data, leading to issues with impurity results for Vancomycin products.