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

Source: https://www.globalkeysolutions.net/records/483/nch-baker-hospital-downtown/09128292-5fbe-4445-aed5-d3d098498333

> FDA 483 for NCH Baker Hospital Downtown on February 26, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NCH Baker Hospital Downtown
- Inspection Date: 2020-02-26
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [483 - 2025-07-10](https://www.globalkeysolutions.net/records/483/nch-baker-hospital-downtown/994f7d8f-eee3-4d3e-a8b6-a29b75966946)

## Related Officers

- [Annette Melendez](https://www.globalkeysolutions.net/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)

Company: https://www.globalkeysolutions.net/companies/nch-baker-hospital-downtown/79e5b468-be16-4bbe-8eb3-cc4189633bbb

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6