# FDA 483 - BTI Filtration - December 03, 2025

Source: https://www.globalkeysolutions.net/records/483/bti-filtration/01d83666-f255-4b9f-ba12-ed122fa5b9b2

> FDA 483 for BTI Filtration on December 03, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BTI Filtration
- Inspection Date: 2025-12-03
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of BTI Filtration in Oklahoma City, OK, revealed one significant observation regarding the firm's quality system. The inspection found that a risk analysis had not been performed for their Class II BTI Filtration Deionization and Carbon Exchange System, which is used in hemodialysis water treatment systems. This indicates a lapse in a critical quality control process for a medical device.

## Related Documents

- [483 - 2023-05-11](https://www.globalkeysolutions.net/records/483/bti-filtration/1dddd35c-a8e0-4cc3-9958-da639c98e505)

## Related Officers

- [Yuliana Hernandez-Magana](https://www.globalkeysolutions.net/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)

Company: https://www.globalkeysolutions.net/companies/bti-filtration/adf592c1-58a3-4de5-859e-a70fe9dba818

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9