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

On September 19, 2019, the FDA issued a Form 483 to Innovative Transfusion Medicine, Inc., a blood bank located at 5753 Miami Lakes Dr, Miami Lakes, FL. The inspection, conducted from September 10-19, 2019, by Investigators Ivan E Reyes and Fabian N Chaparro-Rodriguez, identified five observations.

Observation 1 noted that blood or blood components were collected from an ineligible donor. Specifically, donor (b)(4) donated unit (b)(4), (b)(6), (b)(7)(C) despite being born in a malaria-endemic area and failing to properly document residency history. This unit was processed into Leukocyte RBC and Recovered Plasma and distributed.

Observation 2 cited the failure to maintain donor records, as several Donor History and Physical Examination Forms for deferred donors were unavailable.

Observation 3 detailed inadequate training and experience of personnel responsible for blood collection. Examples included a screener asking about 48 days instead of 56 days for residency, misinterpreting pregnancy questions, and failing to fully explain "xenotransplantation product" during donor screening, leading to ineligible donations.

Observation 4 highlighted failures in establishing, maintaining, and following written standard operating procedures (SOPs). This included lacking an SOP for a Tachometer model (b)(4), not following SOP 3.1 for centrifuge RPM quality control,