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

Source: https://www.keypedia.com/records/483/nch-baker-hospital-downtown/994f7d8f-eee3-4d3e-a8b6-a29b75966946

> FDA 483 for NCH Baker Hospital Downtown on July 10, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NCH Baker Hospital Downtown
- Inspection Date: 2025-07-10
- Product Type: biologics
- Office Name: Florida District Office
- Summary: 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.

## Related Documents

- [483 - 2020-02-26](https://www.keypedia.com/records/483/nch-baker-hospital-downtown/09128292-5fbe-4445-aed5-d3d098498333)

## Related Officers

- [Nerming V. Briones](https://www.keypedia.com/people/nerming-v-briones/b2d9e685-a627-4f9e-854c-0588865fd1b6)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9