FDA EIR - Cardinal Health 414 LLC - April 07, 2021

Cardinal Health 414 LLC in Wichita, KS underwent a routine FDA surveillance inspection from April 5 to April 7, 2021. The inspection focused on the Quality, Production, Facilities and Equipment, and Laboratory Controls Systems for their Fludeoxyglucose F18 Injection, USP PET drug manufacturing, under the Positron Emission Tomography (PET) CGMP regulatory framework. While no formal FDA Form 483 (Inspectional Observations) was issued, the inspection revealed several areas needing improvement. A significant issue was an inadequate investigation into a non-conformance where an expired raw material was used due to an incorrect production picklist. The investigation failed to identify the root causes related to picklist accuracy and the availability of expired materials. Other concerns included a several-month delay in completing final product reviews for numerous batch records and undocumented temperature excursions in a freezer that exceeded internal investigation thresholds. Management committed to reviewing the incomplete non-conformance investigation and was reminded of its responsibility for continuous compliance with the FD&C Act.