NCH Baker Hospital DowntownJuly 10, 2025

FDA 483 - NCH Baker Hospital Downtown - July 10, 2025

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An FDA inspection of NCH Baker Hospital Downtown in Naples, FL, identified a significant issue regarding recordkeeping practices. The hospital failed to maintain proper storage and distribution records, specifically by not obtaining the required physician signatures on emergency transfusion tags. This indicates a lapse in adherence to their own standard operating procedures for emergency blood releases.

Company: NCH Baker Hospital Downtown
Inspection Date: July 10, 2025
Product Type: Biologics
Office: Florida District Office
Person: Nerming V. Briones

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ID · 994f7d8f-eee3-4d3e-a8b6-a29b75966946