FDA 483 - BTI Filtration - December 03, 2025

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.