FDA 483 - Innovative Transfusion Medicine, Inc. - October 07, 2024
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Innovative Transfusion Medicine, Inc. in Miami Lakes, FL, a blood bank, was cited for significant deficiencies during an FDA inspection. The firm failed to properly manage lookback procedures for HIV and HCV reactive donors, including timely consignee notifications. Additionally, the inspection revealed failures to follow written standard operating procedures for equipment calibration and donor follow-up, as well as a general failure to maintain essential records like temperature logs and quality control documentation.
ID · 37190834-4d11-4ea9-92c2-82dfc4c78564