Fresenius Kabi USA, LLC – FDA EIR, Mar 8, 2019

The FDA conducted an inspection of Fresenius Kabi USA, LLC's analytical chemistry control testing laboratory in Melrose Park, IL, from February 27 to March 8, 2019. This facility primarily tests human sterile injectable drug products and warehouses components, operating under Compliance Programs for Drug Manufacturing and Sterile Drug Processes. Although no formal FDA-483, Inspectional Observations, was issued, several verbal objectionable observations were discussed with management. Main issues included inadequate written procedures for ensuring proper maintenance of analytical equipment. More critically, the firm's investigation and proposed corrective actions concerning a newly identified impurity in various finished products were found deficient. These deficiencies involved an insufficient retrospective evaluation of all affected product lots, a failure to adequately explain why an updated testing method did not resolve the impurity, and proposed corrective actions that did not fully address monitoring and criteria for identifying the impurity. Furthermore, a comprehensive manufacturing investigation into the impurity's origin remained incomplete. Fresenius Kabi management committed to rectifying these deficiencies within their ongoing investigation and providing a written update of their findings and corrective actions to the FDA.