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

Source: https://www.keypedia.com/records/483/innovative-transfusion-medicine-inc/0b9b2d47-2775-4fa5-80a3-9240d367afda

> FDA 483 for Innovative Transfusion Medicine, Inc. on September 19, 2019. Product: biologics. 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: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [483 - 2024-10-07](https://www.keypedia.com/records/483/innovative-transfusion-medicine-inc/37190834-4d11-4ea9-92c2-82dfc4c78564)

## 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/86e14ef4-06d2-4b24-9ace-0a5eee5ee9cc

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6