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

Source: https://www.keypedia.com/records/483/innovative-transfusion-medicine-inc/5f1e8b46-f0ea-46f9-87e0-175ef3906132

> FDA 483 for Innovative Transfusion Medicine, Inc. on September 19, 2019. Product: Other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Innovative Transfusion Medicine, Inc.
- Inspection Date: 2019-09-19
- Product Type: Other
- Office Name: Florida District Office
- Summary: 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

## Related Documents

- [483 - 2019-09-19](https://www.keypedia.com/records/483/innovative-transfusion-medicine-inc/aef32bb3-a346-4fbd-9cfa-1e97f9f5937f)

## Related Officers

- [Ivan E. Reyes](https://www.keypedia.com/people/ivan-e-reyes/69bac3eb-f63c-45f0-8420-85a7e06b884a)
- [Fabian N. Chaparro-rodriguez](https://www.keypedia.com/people/fabian-n-chaparro-rodriguez/f14fd931-0830-4a84-a287-2dd85e40195d)

Company: https://www.keypedia.com/companies/innovative-transfusion-medicine-inc/170adb73-0dd3-40d2-af6f-a23ead738ebb

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9