# FDA 483 - Cone Health - February 27, 2024

Source: https://www.keypedia.com/records/483/cone-health/bfa38333-9af9-417c-aa6e-b42ce91df391

> FDA 483 for Cone Health on February 27, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cone Health
- Inspection Date: 2024-02-27
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Cone Health, a hospital transfusion service facility in Greensboro, NC, was inspected by the FDA, revealing deficiencies in its operations. The inspection found failures in maintaining complete records for emergency blood releases, specifically regarding physician signatures. Additionally, the firm's standard operating procedures for emergency blood release lacked clear documentation requirements and responsibility assignments.

## Related Officers

- [investigator](https://www.keypedia.com/people/randy-l-clarida/aae3cc15-a908-4489-9299-7542370ad3cd)

Company: https://www.keypedia.com/companies/cone-health/a11222a3-a1c7-4329-9384-20761f66acf8

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