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

This FDA Form 483 was issued to Innovative Transfusion Medicine, Inc., a blood bank located at 5753 Miami Lakes Dr, Miami Lakes, FL, following an inspection from September 10-19, 2019. Dr. Peter Miller, Medical Director/CEO, was the recipient.

The inspection revealed five observations:

1. **Ineligible Donor Collection:** Blood or blood components were collected from a donor ([b](4)) found to be ineligible due to being born in a malaria-endemic area ([b](4)) and failing to properly document residency details and travel history. The collected unit was processed into Leukocyte RBC and Recovered Plasma and distributed.

2. **Failure to Maintain Donor Records:** The firm was unable to provide Donor History and Physical Examination Forms for a deferred donor ([b](6), [b](7)(C)) with unit number [b](4), (b)(6), (b)(7)(C) collected on [b](6), (b)(7)(C).

3. **Inadequate Personnel Training/Experience:** Personnel responsible for blood collection lacked adequate training and experience. Specific instances included a screener providing incorrect information regarding residency duration (48 days instead of 56), misinterpreting a pregnancy question as only for current pregnancies, and failing to fully explain "xenotransplantation product" during donor screening. Another screener incorrectly advised a donor that the