CSL Behring L.L.C. – FDA EIR, Oct 18, 2018

An FDA pre-approval inspection of CSL Behring, LLC's facility in Bradley, IL, was conducted from October 15 to 18, 2018. This inspection aimed to support a Prior Approval Supplement for the manufacturing of Immune Globulin Intravenous (human) 10% liquid (IGPro10) and was performed in accordance with FDA's guidelines for inspecting biological drug products. The Level II inspection encompassed a review of the company's Quality, Facilities and Equipment, Production, and Laboratory systems. At the conclusion, the FDA issued a Form 483 detailing five observations. A primary documented issue was that certain Corrective and Preventive Actions (CAPAs) lacked appropriate justification for not requiring an effectiveness check, contradicting the firm's own standard operating procedures. CSL Behring was advised to submit a written response to the Form 483 within 15 working days from the close of the inspection if they wished for their response to be considered before the Agency took further action.