FDA 483 - CSL Behring GmbH - March 04, 2022

An FDA inspection of CSL Behring GmbH in Marburg, Germany, a licensed biological drug manufacturer, revealed significant deficiencies. The firm failed to adequately investigate product discrepancies and complaints, including mold and yeast contamination, and lacked sufficient rationale for not investigating retention samples. Furthermore, the facility exhibited poor maintenance with recurring insect infestations, and procedures to prevent microbiological contamination of sterile drug products were found to be insufficient, along with inadequate cleaning validations and issues with vial crimping.