# FDA 483 - BTI Filtration - December 03, 2025

Source: https://www.keypedia.com/records/483/bti-filtration/21921745-e758-4393-98b0-2c3f669e09b7

> 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: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of BTI Filtration in Oklahoma City, OK, revealed a significant quality system deficiency. The firm failed to perform a required risk analysis for its Class II BTI Filtration Deionization and Carbon Exchange System, which is used in hemodialysis water treatment. This indicates a lack of proper risk management for a critical medical device.

## Related Documents

- [483 - 2023-05-11](https://www.keypedia.com/records/483/bti-filtration/1dddd35c-a8e0-4cc3-9958-da639c98e505)
- [483 - 2025-12-03](https://www.keypedia.com/records/483/bti-filtration/01d83666-f255-4b9f-ba12-ed122fa5b9b2)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab