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

Source: https://www.keypedia.com/records/483/innovative-transfusion-medicine-inc/aef32bb3-a346-4fbd-9cfa-1e97f9f5937f

> 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: Food and Drug Administration
- Summary: 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,

## Related Documents

- [483 - 2019-09-19](https://www.keypedia.com/records/483/innovative-transfusion-medicine-inc/5f1e8b46-f0ea-46f9-87e0-175ef3906132)

## 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/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516