# FDA 483 - DCI Donor Services dba Tennessee Donor Services - September 29, 2023

Source: https://www.keypedia.com/records/483/dci-donor-services-dba-tennessee-donor-services/ebc0edf5-d5ea-4119-98c0-a5a07fe1248c

> FDA 483 for DCI Donor Services dba Tennessee Donor Services on September 29, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: DCI Donor Services dba Tennessee Donor Services
- Inspection Date: 2023-09-29
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: An FDA inspection of DCI Donor Services dba Tennessee Donor Services in Nashville, TN, revealed that the firm failed to verify its standard operating procedures for donor eligibility determination were consistent with current CGTP regulations. Specifically, the firm used a contracted SOP that did not adequately screen for sepsis, a relevant communicable disease agent, leading to the recovery and release of tissues from approximately 99 donors diagnosed with sepsis.

## Related Officers

- [Christopher J. Adams](https://www.keypedia.com/people/christopher-j-adams/f7010846-7fd1-4ee8-901a-1015656fea0a)

Company: https://www.keypedia.com/companies/dci-donor-services-dba-tennessee-donor-services/52af9261-495b-4079-b373-b16acedf95df

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea