# FDA 483 - Cumberland County Hospital System, Inc. - January 07, 2025

Source: https://www.keypedia.com/records/483/cumberland-county-hospital-system-inc/35da3dea-cb5c-41dc-840e-d390afcdfa2d

> FDA 483 for Cumberland County Hospital System, Inc. on January 07, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cumberland County Hospital System, Inc.
- Inspection Date: 2025-01-07
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Cumberland County Hospital System, Inc.'s Donor Center in Fayetteville, NC, revealed a significant issue regarding the documentation of donor adverse reactions. The facility failed to prepare and maintain written reports of investigations for all adverse reactions, specifically not recording minor or other reactions in their donor management system or on reaction forms. Only moderate or severe reactions were being captured, indicating a systemic failure in adverse event reporting and record-keeping.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/david-e-lowe/1a2492c2-4a81-4486-b3af-37f6b7b5216a)

Company: https://www.keypedia.com/companies/cumberland-county-hospital-system-inc/451b5321-7f43-44cc-9f2d-58bde3252eb1

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