NCH Baker Hospital DowntownFebruary 26, 2020

FDA 483 - NCH Baker Hospital Downtown - February 26, 2020

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Record Details

NCH Baker Hospital Downtown, a blood bank establishment in Naples, FL, was inspected and cited for deficiencies in maintaining records for blood and blood component processing. Specifically, the firm failed to concurrently document visual inspections and temperatures for irradiated blood products in their "Blood Irradiation Logs." This indicates a significant lapse in record-keeping practices for critical steps in blood product handling.

Company: NCH Baker Hospital Downtown
Inspection Date: February 26, 2020
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
Person: Annette Melendez

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ID · 09128292-5fbe-4445-aed5-d3d098498333