BTI FiltrationDecember 3, 2025

FDA 483 - BTI Filtration - December 03, 2025

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Record Details

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.

Company: BTI Filtration
Inspection Date: December 3, 2025
Product Type: Device
Office: Division of Human and Animal Food Operations - West III
Person: Yuliana Hernandez-Magana

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ID · 21921745-e758-4393-98b0-2c3f669e09b7