FDA 483 - CSL Plasma Inc. - February 15, 2022
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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.
ID · 53c51154-fd17-4bdb-a74c-d5f043c4ddb6