# FDA 483 - Emory University Hospital Midtown- Center for Transfusion & Cellular Therapies - April 28, 2017

Source: https://www.keypedia.com/records/483/emory-university-hospital-midtown-center-for-transfusion-cellular-therapies/89ae8064-6e46-4add-b769-14aae47ead73

> FDA 483 for Emory University Hospital Midtown- Center for Transfusion & Cellular Therapies on April 28, 2017. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emory University Hospital Midtown- Center for Transfusion & Cellular Therapies
- Inspection Date: 2017-04-28
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Emory University Hospital Midtown - Center for Transfusion & C. in Atlanta, GA, revealed significant deficiencies in their blood bank and transfusion service operations. The firm failed to make timely notifications to recipients during HCV look-back investigations and did not consistently adhere to its written standard operating procedures for blood product handling, record-keeping, and tracking. These issues indicate a lack of robust control over critical processes for blood and blood component management.

## Related Officers

- [investigator](https://www.keypedia.com/people/cordelia-j-brammer/57662881-a90a-461d-ac4d-8c1bc18a333e)

Company: https://www.keypedia.com/companies/emory-university-hospital-midtown-center-for-transfusion-cellular-therapies/06bf6f2c-3d85-4814-bfe7-6e1d8b2813c5

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7