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

Source: https://www.keypedia.com/records/483/cumberland-county-hospital-system-inc/a9f70691-34b0-4e9b-abb1-f7ceaab549c7

> 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: FDA District Office — Atlanta, Georgia
- Summary: Cumberland County Hospital System, Inc. in Fayetteville, NC, a Donor Center, was inspected by the FDA. The inspection revealed that the facility failed to prepare and maintain written reports of investigations for all donation-related donor adverse reactions. Staff were found to be inconsistently documenting reactions, primarily capturing only moderate or severe events.

## Related Documents

- [483 - 2025-01-07](https://www.keypedia.com/records/483/cumberland-county-hospital-system-inc/35da3dea-cb5c-41dc-840e-d390afcdfa2d)

## 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/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43