Ulrich Medical USA IncMarch 17, 2025

FDA 483 - Ulrich Medical USA Inc - March 17, 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 Ulrich Medical USA Inc

Record Details

Ulrich Medical USA Inc, a specification developer for spinal implants and instrumentation in Plano, TX, received one repeat observation during an FDA inspection. The firm's complaint handling procedures were found to be inadequate, specifically regarding the processing of complaints for parent company products and the identification of non-conformance trends. This indicates a recurring issue with the firm's quality system.

Company: Ulrich Medical USA Inc
Inspection Date: March 17, 2025
Product Type: Device
Office: Dallas District Office
Person: Jacey Roy

Open in Dashboard

ID · d1219ff3-2dce-4a44-9c06-3b07259d2e3e