# FDA 483 - Presbyterian/St. Luke's Medical Center Donor Services - January 26, 2017

Source: https://www.keypedia.com/records/483/presbyterianst-lukes-medical-center-donor-services/0dfa5f02-ee8a-4a25-88ce-5a70fa488795

> FDA 483 for Presbyterian/St. Luke's Medical Center Donor Services on January 26, 2017. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Presbyterian/St. Luke's Medical Center Donor Services
- Inspection Date: 2017-01-26
- Product Type: biologics
- Office Name: Denver District Office
- Summary: HealthOne Presbyterian/St. Luke's Medical Center's hospital blood bank was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate record-keeping practices, including failure to document technician identities, maintain concurrent records, and conduct thorough investigations into discrepancies. Additionally, the facility failed to adhere to standard operating procedures for blood component processing and ensure proper donor consent for apheresis procedures.

## Related Documents

- [EIR - 2017-01-26](https://www.keypedia.com/records/eir/presbyterianst-lukes-medical-center-donor-services/5a3af212-e013-4e8d-9f9d-964f869a6eb7)
- [EIR - 2019-04-22](https://www.keypedia.com/records/eir/presbyterianst-lukes-medical-center-donor-services/87a4616c-94e7-44d0-b669-415abafcd35c)

## Related Officers

- [Manager, Data Science and Engineering](https://www.keypedia.com/people/kelly-d-moore/a5778f12-e968-4fc9-8391-b2cb5753232a)

Company: https://www.keypedia.com/companies/presbyterianst-lukes-medical-center-donor-services/5fb3f1cd-327f-47e0-bc14-cd94277fe76a

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face