FDA 483 - Versiti Indiana Inc - May 07, 2019

An FDA inspection of Versiti Indiana Inc, a blood bank in Indianapolis, revealed significant deficiencies in equipment maintenance, labeling, record-keeping, and adherence to standard operating procedures for HCT/Ps and blood products. Issues included unmaintained cryogenic freezers, improperly labeled tissues, unrecorded storage temperatures, and missing or incomplete documentation for processing and distribution steps. These observations indicate a lack of control over critical processes impacting product quality and traceability.