Cone HealthFebruary 27, 2024

FDA 483 - Cone Health - February 27, 2024

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Record Details

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.

Company: Cone Health
Inspection Date: February 27, 2024
Product Type: Biologics
Office: Atlanta District Office
Person: Randy L. Clarida (investigator)

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ID · bfa38333-9af9-417c-aa6e-b42ce91df391