Fresenius Kabi USA, LLC – FDA 483, Jun 13, 2023

An FDA inspection of Fresenius Kabi USA, LLC in Wilson, NC, a sterile drug manufacturer, revealed six observations concerning significant deficiencies in aseptic processing controls. Issues included inadequate procedures to prevent microbiological contamination, insufficient validation of aseptic processes, and failures in production and laboratory controls. Additionally, the firm's batch records were deficient, and there was a failure to thoroughly review unexplained discrepancies.