FDA 483 - Fresenius Kabi USA, LLC - February 05, 2019

An FDA inspection of Fresenius Kabi USA, LLC, a sterile drug manufacturer in Wilson, NC, revealed significant deficiencies in aseptic processing and quality control unit responsibilities. The firm failed to adequately validate cleaning procedures for aseptic equipment and lacked proper Quality Assurance oversight in the release of manufacturing equipment. These issues indicate a lapse in maintaining aseptic conditions and adherence to quality control procedures.