FDA 483 - Innovative Transfusion Medicine, Inc. - September 19, 2019

Innovative Transfusion Medicine, Inc. in Miami Lakes, FL, a blood bank, was cited for multiple significant deficiencies during an FDA inspection. Observations included collecting blood from an ineligible donor, failure to maintain donor records, inadequate personnel training for donor screening, and widespread non-adherence to and lack of standard operating procedures. Additionally, the firm failed to standardize and calibrate critical equipment used in blood collection.