FDA 483 - Fresenius Kabi USA, LLC - June 29, 2018

An FDA inspection of Fresenius Kabi USA, LLC in Grand Island, NY, revealed six observations concerning significant deficiencies in manufacturing controls and quality systems. The firm failed to evaluate material compatibility, maintain complete batch records, and adhere to written procedures for cleaning validation. Additionally, issues were noted with timely Field Alert Report submissions and the quality control unit's written procedures and oversight of contract laboratories.