FDA 483 - CSL Plasma Inc.

CSL Plasma, Inc. in Baltimore, Maryland, was issued a Form FDA 483 following an inspection from December 14-16, 2016, citing two observations. The firm failed to consistently notify deferred donors of transfusion-transmitted infection test results and did not adequately examine donor phlebotomy sites for signs of infection or drug abuse. These findings indicate significant deficiencies in donor management and screening procedures.