FDA 483 - CSL Plasma Inc. - February 15, 2022

CSL Plasma Inc. in Dallas, TX, was cited for three significant observations related to plasma collection and record-keeping practices. The inspection revealed failures in reporting adverse donor reactions, adhering to standard operating procedures for quarantining HCV-positive plasma units, and maintaining accurate and traceable donor records. These issues indicate a lack of robust quality control and documentation practices in critical areas of blood component collection.