FDA 483 - Specialty Blood Center - December 16, 2019

Vitrologic, Inc., dba Specialty Sera, a whole blood donor center in Charleston, SC, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm failed to properly document and timely notify deferred donors of reactive test results, including HIV, HCV, and RPR. Additionally, the responsible physician did not conduct required medical assessments, and finished frozen plasma units lacked the necessary caution statement for components of medical devices.