# FDA 483 - DCI Donor Services - December 19, 2019

Source: https://www.keypedia.com/records/483/dci-donor-services/080d97ef-d029-4279-9330-1785b9b6f68c

> FDA 483 for DCI Donor Services on December 19, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DCI Donor Services
- Inspection Date: 2019-12-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of DCI Donor Services in West Sacramento, CA, a human tissue establishment, revealed significant deficiencies in donor screening and facility procedures. The firm failed to adequately screen placenta donors for communicable diseases like West Nile Virus and lacked proper written procedures for HCT/P donor eligibility determinations, including for Zika Virus. Additionally, the facility did not follow its established cleaning and decontamination procedures for surgical recovery suites.

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)

Company: https://www.keypedia.com/companies/dci-donor-services/773b247c-d86c-4dbc-af92-f050f5188181

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b