BTI FiltrationDecember 3, 2025

FDA 483 - BTI Filtration - December 03, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore BTI Filtration

Record Details

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.

Company: BTI Filtration
Inspection Date: December 3, 2025
Product Type: Device
Office: Dallas District Office
Person: Yuliana Hernandez-Magana

Open in Dashboard

ID · 01d83666-f255-4b9f-ba12-ed122fa5b9b2