FDA 483 - Biological Specialty Company, LLC dba BioIVT, LLC - February 13, 2020

Biological Specialty Company, LLC dba BioIVT, LLC in Allentown, PA, a component preparation and collection facility, received a Form 483 with two observations. The inspection revealed significant issues with record-keeping for the final disposition of viral reactive whole blood units and improper storage of critical supplies and reagents. These findings indicate deficiencies in maintaining adequate control over blood product distribution and facility conditions.