CSL Plasma Inc. – FDA EIR, Sep 19, 2019

A pre-approval FDA inspection of CSL Plasma, Inc.'s new Source Plasma facility at 1845 Elmwood Avenue, Buffalo, New York, was conducted from September 17-19, 2019. The inspection, carried out by the Center for Biologics Evaluation and Research (CBER) under CPGM 7342.002, aimed to supplement the firm's U.S. license for manufacturing Source Plasma. While no Form FDA-483 (Inspectional Observations) was issued, the inspector discussed several concerns with management. These issues included inconsistent reporting of syphilis test results (preliminary vs. confirmatory) and other transfusion-transmitted infection results to the Health Department, discrepancies in collection and visit numbers across various internal reports (e.g., Donor Adverse Event, Error Management Forms, Overharvest investigations) and the plasma processing system, and delays by Quality Assurance staff in closing out Issue Reports within specified timeframes. A potential contamination risk during phlebotomy arm preparation was also noted, with phlebotomists sometimes positioned too close to the arm cuff. Management was advised to ensure phlebotomists maintain adequate spacing and to reinforce adherence to all established procedures. The inspection covered various aspects of plasma manufacturing and daily operations, excluding distribution.