FDA 483 - Physician's Plasma Alliance Inc. dba Biological Specialty Company dba - April 12, 2019

An FDA inspection of Physicians Plasma Alliance LLC, a plasma and blood collection center in Johnson City, TN, revealed a significant deficiency in their adverse reaction reporting and follow-up procedures. The firm failed to prepare and maintain written reports of investigations into adverse reactions and did not follow up with three donors who experienced reactions during blood or plasmapheresis procedures. This indicates a lapse in donor safety protocols and record-keeping practices.